Phase 3 clinical trial

cher76

On October 5,2010 my husband Rickie was diagnosed with EC. He is 54 years old. He had been having some pain in his upper stomach starting in the spring and thought he was developing an ulcer. He cut down on his eating and began to lose weight all the while telling me he was dieting. During later summer he began to have trouble swallowing and finally when he started dropping 8 to 10 pounds a week I insisted he see a doctor. We live in the very tip of Texas and when our local gastrointestinal doctor did an endoscopy and said he had never seen anything like it before, I knew we needed to be treated elsewhere. We immediately self referred to MD Anderson in Houston. We had our first appointment there on October 19, 2010. Between the time of the diagnosis and our appointment eating had become so difficult that Rickie was only eating pureed foods and was still losing weight at the rate of 2 to 3 pounds a day. In the spring he had weighed 275 lbs and was down to 210 at the first appointment. He was given a PET scan, an endoscopy and a bronchoscopy as well as blood tests and chest x-rays. On Oct. 26th we were told that the tumor was quite large, measuring 20 cm. encompassing all of the esophagus and 4 cm into the stomach. Several lymph nodes showed signs of cancer and there was also a hot spot on his upper spine and slightly on his lower hip. Radiation was out and palliative care with chemo was recommended. His first treatment started on Nov 5 with an intravenous infusion of Oxaliplatin,Docetaxel, and Fluorouracil (5-FU). The first two drugs were administered over 5 hours there at MDA and the last one was hooked up to a fanny pack pump that stayed connected for 48 hours. the treatments were every 2 weeks for 4 rounds and then we came back for another PET Scan. During the weeks of chemo he has regained the ability to swallow whole foods and and has held his weight at 200 lbs. He had very few side effects fro the chemo, the worst being severe constipation the first treatment, which he has managed to learn how to treat by eating fiber and taking Miralax. He has been feeling good and going about somewhat of a normal routine with the exception that his energy level is somewhat low. Yesterday he had his PET Scan and today we had a consultation with his oncologist, Dr. Ajani. We were really hoping for good news...what we got was mixed. The tumor seems to have shrunk a little in the esophagus and the spots on the spine are no longer there, however there is now a spot on a lymph node on his neck and in more lymph nodes around the esophagus. So basically it helped in some areas but it seems that the cancer has moved to other areas. Dr. Ajani feels that the chemo is not working and advised he wants to remove the docetaxel and replace it with Irinotecan. Or he suggested that we could try a clinical trial of IMC-1121B. This is a drug that keeps the cancer cells from producing blood vessels to feed itself with. This is a phase 3 double-blinded study with 2 out of every 3 patients getting the drug and 1 patient a placebo. This is the decision we are now faced with. The drug is administered every 2 weeks and after the 3rd round a CT scan is taken. The patient can at any time opt out of the study. I have not been able to find alot of info about this drug on the internet. Our concern is that if he ends up getting the placebo how will 6 weeks without treatment affect him. No one will know (including us) if he has the drug or the placebo. Scary to think about. If anyone has been involved in the phase 1 or 2 of these trials please let me know. We are trying to get all the info we can to help us make a decision.

unclaw2002

clinical trial
Cher I posted this on William's repost as well.

Cher,

I just saw your post. I am at work and have meetings the rest of the afternoon so I can't answer you in depth. My father is participating in the clinical trial you mentioned at MD Anderson and I will post later tonight with more details. In the meantime if you want to visit his caring bridge website at http://www.caringbridge.org/visit/harrycollins2/guestbook. There is more detail there about his cancer and his experience with the clinical trial in his journal. I am happy to speak to you just send me a message with your contact information and I will get in touch.

This trial went from Phase I straight to Phase III and the researchers have not posted the results of the first Phase, althought they must be pretty impressive to have skipped Phase II. If you reseach the drug and IMCLONE you will find press releases, especially European which speak about the anticipated future market for this drug as a breakthrough treatment. We are hoping that my dad is getting the experimental drug.



Best,
Cindy

unclaw2002

Cheryl,First let me say I
Cheryl,

First let me say I am sorry to hear about your husband’s situation. It is as difficult road. This is a rather lengthy response so take some time to absorb as William would say And I share this for others who may have some of the same questions but haven't posted.

Perhaps some background on my dad may help you understand his situation and his process in evaluating participating in the clinical trial. He was 78 when diagnosed with Esophageal Cancer in December of 2009, with complications from high blood pressure and diabetes controlled by medicine and he had some hearing loss due to age and job related injuries. He was T3, N1, MO and a surgical candidate. the end of January he began a combination of taxol and carboplaton, chemo once a week. After the first round of 6 weeks they added radiation along with the chemo. At this point he was saying he believed the chemo and radiation could cure him.

My dad started the chemo and seemed to tolerate the chemo at first. He had some low blood counts and his blood sugar went out of control because of the steroids. He never had much nausea (the meds seemed to help) and his main side effect was extreme fatigue. His blood counts however made him miss several normal courses of treatment so things got extended. Then when he started his second round of chemo they added the radiation. The chemo and radiation at first appeared to be working – his SUV’s on subsequent tests in March appeared to be dropping and we were all very excited.

Then in April, he began to have real serious problems and we will never know what caused them or if it was a cascading effect. The radiation began to shrink the tumor so the stent put in his esophagus so he could swallow, fell into his stomach. He began to have severe pain, he went to the doctors they didn’t identify the problem right away, he got dehydrated and because he is stubborn and the doctors didn’t get him in the hospital right away he became very weak and had to be admitted to the hospital (we thought we might lose him) and his chemo/radiation was interrupted again and he became really debilitated. My dad went from being independent to having to use a wheelchair, walker cane and not being able to walk or drive without help. Mind you my dad was/is once again a very active person out all day driving and doing things so this was devastating – plus my mom doesn’t drive. And worst of all when they took the stent out of him the first time they put another one in. So he is discharged and once he is a little stronger they try to finish the chemo and the radiation process. This time it is worse and the stent drops again, he is severely dehydrated, develops a urinary tract infection and nearly dies. He is in the hospital for over three weeks and moved to a rehab hospital for another 4 plus weeks. By the time he is out of the rehab hospital he is so weak and unable to get around on his own it scares all of us how weak he is.

In the meantime the next scan at the end of June shows - no lymph node involvement, no activity in the esophagus, but now the cancer has metastasized and he has two spots in the liver, one in each node, no other active spots anywhere else. The liver biopsy confirms that the liver tumors are esophageal cancer. So now my dad is now Stage IVb – and no longer a surgery candidate. He is so debilitated we aren’t sure he can tolerate any type of treatment. The doctors are telling us that given his physical shape we may not have much time left with him.

Standard treatment for mets to the liver is Folfox a chemotherapy regimen that incorporates folinic acid, fluorouracil-5FU (F), and Oxalipatin. But the doctor’s thought that would kill my dad because he wasn’t strong enough - they prescribed just the 5FU via 48 hour infusion every two weeks. The 5FU was really hard on my dad, his platelet counts went really low, so they cut the dosage and administered the lower dosage every week, but that didn’t help and his blood counts kept going lower. As a result he would go several weeks without any treatment. Of course I am sure you know that being able to consistently receive the chemo without planned breaks is essential to obtaining the maximum effectiveness from the treatment.

He wasn’t a candidate for any of the liver embolism procedures, resection operations, or the theraspheres so those were not treatment options. By the last week of September his platelet counts were in the low 70ks and the doctors said they couldn’t give him and more chemo until his platelet count got over 100k. We watched and they stayed low throughout October.
In October they did another scan and the tumor had started to grow in his esophagus again, and he had another tumor in his liver and the previous two tumors had continued to grow. He couldn’t have any more radiation. And his platelets were so low they couldn’t give him any chemo either.

In early November the doctors said that there wasn’t much that could be done. He was being treated at Ocshner Hospital in New Orleans and consulting with Sloan in NY City. The doctors said that the original chemo hadn’t worked because the cancer had returned in less than 6 months. Also they said that the chemo was killing my dad and that he wasn’t tolerating it very well. The doctor at Sloan said they could try the 5FU again and add Oxiplatin to the mix, which might make it more potent against the liver tumors if he could possibly tolerate the drugs. There weren’t any Phase III clinical trials that Sloan was doing at that time that were open that he could qualify for.

My mom and I began talking about his quality of life and we discussed the possibility of doing nothing because he was starting to feel better having been off chemo since the beginning of October. And if truly he only had months to live, not years to live then perhaps enjoying life and doing things on his “bucket list” would be better. We didn’t want his last months on earth to be spent in doctor’s offices doing useless chemo that wasn’t working and would only kill him faster. We shared with him the from the Mayo Clinic about when is enough. (The article is at the end of this post for any who want to read it). My dad wasn’t there yet though and he still wanted to fight on --- it was his life and he wasn’t ready to check out or say he was going to stop treatment. But he did understand our concerns so when he went in to see the doctor again to discuss treatment options he asked a very important question. “What would you prescribe and do if I were your father?” And the doctor, to her credit was candid with my dad. She said that she would probably discontinue chemo because of the debilitating side effects he had experienced and the fact it didn’t seem to work or help fight the cancer. She said she would urge her father to enjoy his last days, but that she would check to see if there were any Phase III, and only Phase III trials that might be available that could offer some experimental drug. If there was a Phase III trial she would have her dad do that.

So we checked all over the country and found the clinical trial at MD Anderson. And my dad was able to qualify. We too were concerned about the possibility of not getting the experimental drug. A couple of things that went into my dad’s analysis. He wasn’t sure he was going to take any more chemo, but I’m not sure about that and if he gets kicked out of the trial he wants another plan. But as to odds he said that since his diagnosis his odds have been pretty bad, a 66% chance seemed pretty good to him to trade “ a months to live prognosis --- for a potential 40 months more of life (4 years).” And he said at that point he had been off the chemo for essentially 2 months . . . he has had the three infusions and then will get the scan result later this month. He looked at it as giving his body a break from the toxic soup and if needed he can go back on another course of chemo. But the chance to receive a ground breaking drug that shows so much promise to him outweighed the risk. At the end he said he would be getting the best palliative treatment and he is monitored and checked. And the scientist in him said maybe some good could come to others in finding better treatments to this cancer. This wasn’t an easy decision but he seems fine with it. He really has been impressed with the staff and Dr. Ajani and as I said has spoken to him that if he gets kicked out of the trial at the end of the month he wants to see what else might be available.

There isn’t a lot on the internet about this drug. But what I have found is that it appears to hold a lot of financial promise for IMCLONE and the news articles I have found seem to indicate it is going to have a huge market when it gets out of the clinical trials. Unfortunately for us the efforts seem to be focused more in Australia and Asia than in the US. There aren’t a lot of patients and information here in the US you can dig up.
I am going for the scan and meeting with Dr. Ajani on the 20th . That will be the first time I meet Dr. Ajani and the Staff at MD Anderson.

At the end of the day my dad has been feeling great, doing things again and driving. His quality of life has improved dramatically. Yes he is still tired, and he can’t go into big crowds, and he can’t eat the way he used to and has pain from time to time. But in all this has been good for him he had a wonderful holiday season and has hope he is getting the drug. As my dad saw it he didn’t have a lot to lose since the chemo wasn’t working, and was making him so sick. If he got the miracle drug then he might get a couple more years and if he didn’t then at least he would be receiving some good pain drugs and care at a top cancer hospital.

Best,
Cindy


MAYO CLINIC
Stopping cancer treatment: Deciding when the time is right

Explore what it means to stop your cancer treatment — from what to consider when deciding, to what to expect once cancer treatment ends.

You've come a long way. You made it through your initial cancer diagnosis and the shock and fear that came with it. You've been through cancer treatment and the related side effects.

But for all you've overcome, if your cancer treatment isn't working as you and your doctor had hoped, you may face another tough step in your journey with cancer. You may eventually need to consider ending your cancer treatment.

As you and your doctor decide whether or not to stop your cancer treatment, take time to gather information and assess your goals. What you find might help you understand that stopping your cancer treatment isn't necessarily giving up. Rather, it's a way to gain more control over how you'll spend the rest of your life.

__________Changing your cancer treatment goals

When you were first diagnosed with cancer, you and your doctor probably discussed what sort of results you could hope for from your cancer treatment. You probably hoped that your cancer would be cured. But if your first line of cancer treatment didn't work as well as you had expected, you might have realized that your goal of a cure was no longer possible and that you needed to refocus your goal.

In life, whether dealing with cancer or anything else, goals aren't fixed and static. Goals must remain flexible and change with the circumstances. This is true when dealing with cancer. Though your first goal, reasonably, is one of cure, sometimes treatment doesn't go as you had hoped. Cure may no longer be a realistic option. Readjusting your goals can help you focus on those things you can still reasonably control.

Throughout your cancer treatment, three phases or goals of care exist. When you move from one phase to the next is up to you and your doctor.

 The quest for a cure. During this phase you and your doctor hope to cure your cancer. You might be willing to put up with a large number of temporary cancer treatment side effects for the very large payoff — to be cured. If your cancer goes into remission, your goal might now be to maintain your health and make sure your cancer doesn't return.

 Prolonging your life. If your cancer treatment doesn't proceed as expected, or if your cancer was diagnosed at a more advanced stage, the goal of being cured might not be realistic. If this is the case, a reasonable goal might be to control or shrink the cancer or prevent it from spreading. You might be willing to put up with some side effects of cancer treatment.

 Comfort rather than cure. A time may come when further treatment has little chance of prolonging your life or of shrinking your cancer. In this setting, trying to achieve the highest possible quality of life is a reasonable goal. Side effects must be kept to a minimum because any benefits are likely to be small. At this point, you and your doctor work to keep you feeling as symptom-free as possible. You might now focus your goal on your family and relationships, rather than your cancer. This can be a time of great comfort and even personal growth.

Your treatment goals are never static, and you and your doctor should continually discuss your goals — slowly and gradually adjusting them based on your individual circumstances. The process is very gradual and evolves throughout the course of your illness.
Making the decision to end treatment

Making the transition to comfort and symptomatic (palliative) care can be a difficult choice. Talking about your decision with your doctor and your family might help you sort out your feelings. Some points you might want to discuss include:

 What's your current condition? Ask your doctor to be honest about your cancer and its progression. And be honest with yourself. Denying that your cancer is progressing, while a natural response, might prevent you from being able to make the most of your time.

 What's your treatment doing? Is it shrinking your tumor? Is it fighting your cancer? What benefits is it providing, if any? Think about the pros and cons of your treatment.

 Why are you getting treatment? Is it to shrink the cancer and live longer? What are the chances of this happening? Is it to relieve a symptom, such as pain? Is it working for that symptom? Are you getting these treatments for yourself, or is it because someone in your life wants you to? Is there pressure from your family? Is it worth it? Many people with advanced cancer want to try every possible treatment, for fear they'll let down their loved ones if they don't. But sometimes, getting ineffective treatments only takes you away from your family and loved ones for longer periods of time.

 What's the downside to treatment? What side effects do you experience? Are they mild or are they intolerable? To what extent does the treatment limit your ability to participate in the activities you enjoy? Consider your quality of life.

 Is the downside worth it? For the benefit you're receiving from your treatment, are the side effects worth it?

 What do you want for your future? Will continuing your treatment prevent you from taking part in those activities?
In your decision to end your treatment, take into consideration your religious beliefs and other personal values. Discussions with your religious adviser can help you focus your goals.

__________Discussing the end of your treatment with your doctor

In a perfect world, the decision of whether or not to end your treatment will be thoroughly discussed between you, your doctor and your loved ones. Your doctor would be sure of the potential benefits of your treatment. And you would be open with your doctor about your fears and hopes for your future.

In truth, your doctor might find your prognosis difficult to estimate, and you might be afraid to admit feelings of depression or anxiety. For this reason, it's important that you and your doctor have adequate time to ask each other questions and not be afraid to ask or answer difficult questions about your future.

Many times you and your doctor will agree with each other on whether to continue treatment. But in some cases, you might disagree.

__________When your doctor wants to end your treatment, but you don't

If your doctor approaches you about ending your cancer treatment, you might feel betrayed. You might feel like your doctor wants to give up on you. Maybe you've been denying the fact that your cancer treatment isn't working, and you aren't ready to accept the fact that it might be time to stop.

Know that your doctor has your best interests in mind, and listen to your doctor's reasoning. Ask questions. Be honest about how the thought of ending your treatment makes you feel. Just because your doctor suggests no longer treating your cancer, your doctor will always continue to treat you, to assure comfort and relieve symptoms to the best of his or her ability. Ask to see X-rays and other tests that show the progression of your cancer. This might help you better understand your doctor's opinion.

You might be reluctant to stop your treatment because you're afraid to lose control over your health. You might also equate ending treatment with giving up. But you can maintain both control and hope without the cancer treatment:

 Maintaining control. Deciding you don't want any more cancer treatment is a form of control in and of itself. Taking away the treatment means you can have more time with friends and family without the side effects keeping you sidelined. You can control your pain so that you can have a better quality of life. And you still have control over several aspects of your own care, such as what you do and who you see.

 Restoring hope. If until now hope has come from your expectation of a cure, then ending your treatment might seem like giving up hope. But you can draw hope from other places. Time with friends and family and the comfort your loved ones bring can provide hope, too. Terminally ill people often say that hope comes not from treatment, but through connections with others, spirituality and uplifting memories.

If, after discussing your treatment with your doctor and your family, you decide you don't want to stop your treatment, your doctor may be willing to continue treatment. However, if your doctor knows the treatment will only hurt you, he or she can refuse to treat you. If that happens, you can request a review of your case with the hospital or clinic management. Or you can get a second opinion from another doctor.

__________When you want to end your treatment, but your doctor doesn't agree

Sometimes pain and other side effects can make your cancer treatment unbearable. This may influence your decision to stop treatment — even if your treatment seems to be working. But pain and side effects can sometimes be remedied so that you're more comfortable as you go through your cancer treatment. Talk to your doctor about getting help for symptoms such as:

 Pain. Without proper pain control, you might feel like abandoning your treatment before you've given it time to work. A number of solutions — from drugs to complementary therapies, such as meditation — can help you control your symptoms. Your doctor can't detect the severity of your pain, so it is up to you to speak up.

 Anxiety. It's normal for you to be anxious about what is happening to your health. Anxiety about your future and your family's future — financial, emotional and otherwise — are completely normal. Medications might help you relieve your anxiety. But talking with your doctor or another health care professional can also help you sort out your feelings and provide relief.

 Depression. Depression is common in people with cancer. But those feelings of hopelessness can contribute to your physical symptoms, making you think you're worse off than you really are. Medications are available for depression, and talking about your feelings can help. Physical signs and symptoms of depression, such as weight loss and fatigue, are difficult for your doctor to diagnose since they can also be caused by your cancer. So tell your doctor if you think you might have depression.

After these factors are controlled, you might be in a better frame of mind to make a decision about continuing your cancer treatment. Don't accept pain, anxiety and depression as part of your cancer — they can all be controlled to some extent most of the time.

If you simply don't want to continue treatment, that's OK. It's not a sign of weakness. When to stop treatment is a highly personal decision. You can always change your mind and restart your treatment if your doctor agrees.

In the end, it's your decision to make, but input from your doctor, other health care workers and your friends and family can be an important part of the decision-making process.

__________Telling your family and friends

If you decide to end your cancer treatment, be honest and open with your family and friends when telling them. Talking about your feelings can be therapeutic. It can also help your friends and family come to terms with your decision to end treatment. They'll better understand what they can do to help you and how you want them to behave toward you. You might prefer to keep your feelings to yourself, and that's OK too.

It's possible that your friends and family might not understand your decision because of fears about your future or theirs. Talking about your decision to end your treatment and your change in goals might help them overcome these fears.

If you have difficulty talking with your friends and family or if they have difficulty accepting your decision, talk to someone trained in counseling, such as a nurse, social worker, psychologist or a member of the clergy. That person might have ideas for you to make talking with your friends and family easier.

Your friends and family may just need time to adjust to your decision. Let them know you want them close and still need their support.

Talk with your family about your wishes for the future — called advance directives. Discuss whether you'd want to be kept alive if machines were breathing for you. Appoint someone to make health care decisions for you if you were to become incapacitated.

___________What to expect after your treatment ends
If you decide to end your treatment, it doesn't mean you'll stop being cared for by doctors and nurses. You and your doctor will discuss your options. You might have a loved one or friend who wants to help take care of you. Or you might decide to use a home nursing service.

No matter what you choose, you'll still have regular checkups to make sure your pain is kept at bay and that you're comfortable. Your doctor might have you seen by another doctor who specializes in palliative care — a doctor whose main focus is to make you comfortable, not cure you.

Stopping your treatment doesn't mean you'll die immediately. After you end treatment, you could still be active and care for yourself for many months. It's also possible your health could deteriorate rapidly. How long you'll live after ending your treatment will vary depending on the type and stage of your cancer, as well as other health problems you may have.

 Whether you want to stay at home is up to you and will depend on the level of care you need. You might feel more comfortable in a hospital or nursing home with doctors and nurses nearby at all times. Or you might prefer the comfort of your home with a nurse to check in on you every day. You might choose a hospice program, which is designed for people who generally aren't expected to live more than six months.
More time for what matters

 When ending treatment makes you pain-free and more able to participate in various daily activities, you might find you have more time for friends and family. Being able to be cared for at home might mean you could keep up with hobbies or activities that make you happy.

By Mayo Clinic Staff
Feb 20, 2006
© 1998-2006 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.com,"

Callaloo

Thank you Cindy
Cindy, that was one of the most helpful posts on what to do when treatment options and the patient are exhausted, but a fighting spirit remains. Your father is so courageous it brings tears to my eyes. He is an inspiration to us, to me.

Cheryl, my heart goes out to you and your husband. You are facing what all of us with advanced incurable EC face, now or soon: what to do when the chemo doesn't work.

William mentions Bailey, a poster whose husband has gone through several different chemo regimens and has chosen to stop all treatment. Your husband has only gone through one. Should he now try irinitocan? William talks about his 2 rounds of oxaloplatin and 96-hr infusions of 5FU, indisputably an aggressive regimen. But I had four such 96-hour infusions, and I am not cured. I've read many posts on this board looking for some clue. Jane's husband Charlie had Herceptin. Jan's husband Tom had Erbitux. Drugs we are all clamoring to get.

There is no magic bullet.

Your question is a legitimate one-- what is the downside to going 6 weeks on a placebo? Compared to what? Is there a downside to doing another round of chemo and then, if it doesn't work, entering the trial at a later time? These are questions that cannot be answered on this board. So much depends on the medical fitness, blood work, history, etc., of the patient. These are questions for his doctor, and your husband needs a doctor he can trust. Your husband is at what is considered to be one of the best cancer centers in the country. Dr. Ajani is a well-known expert in the field. Is he advocating another round of chemo or the trial? If he's advocating the trial over chemo, is he too closely aligned with the trial and is he trying to recruit for the trial? Maybe a second opinion is in order. But in the end, your husband has to call it. And a lot of the analysis is contained in Cindy's post.

Good luck to you. I wish you and your husband the best.

Lu

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