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This drug trial for recurrent ovarian cancer is over.

california_artist's picture
california_artist
Posts: 860
Joined: Jan 2009

Since ovarian cancer is a serous and the separate arm of the uterine was determined til the mid eighties, I'm putting the link to information on this trial. It is my understanding that once you have gone through chemo/raditation, you are eligible to take drugs that might not yet have FDA approval for the cancer you have. This trial involved taxol and carbo plus Vorinostat.

If you go to the web site and print out the data, there's a possibility you can make your doctor look into it for you.

Intervention Details:

Drug: Paclitaxel, Carboplatin and Vorinostat
Intravenous paclitaxel (175 mg/m2) and carboplatin (AUC 5) and oral vorinostat 400 mg day 1-14 every three weeks.
Here's the url:

http://clinicaltrials.gov/ct2/show/NCT00772798

Here's the blurb. It's easier to read on the site, but I wanted you to have an opportunity to see what it was all about. You can see the new drug is a pill.

ClinicalTrials.gov Identifier: NCT00772798

Purpose
TITLE:A Phase II non-comparative study of paclitaxel plus carboplatin in combination with Vorinostat in patients with advanced, recurrent epithelial ovarian cancer. INDICATION:Second-line treatment of patients with recurrent platinum-sensitive epithelial ovarian cancer. RATIONALE:Recurrent epithelial ovarian cancer is today an incurable disease. The current standard of care consists of systemic chemotherapy using either carboplatin plus paclitaxel (in platinum-sensitive patients) or single agent chemotherapy with agents like liposomal doxorubicin, topotecan, weekly paclitaxel or gemcitabine (platinum non-sensitive patients). The outcome for patients with advanced ovarian cancer nevertheless remains poor.Preclinical evidence suggests that vorinostat, a potent histone deacetylase (HDAC) inhibitor, may potentiate the antitumor activity of paclitaxel and/or carboplatin. The study will assess whether the addition of vorinostat to paclitaxel plus carboplatin is manageable and induces reasonable response rates in patients with advanced recurrent, platinum-sensitive ovarian cancer. Biomarkers will be collected from both primary tumors and biopsies before and after start of treatment with vorinostat.

DESIGN:Phase II, single-center study. All eligible patients will be treated with intravenous paclitaxel plus carboplatin plus oral vorinostat. Patients will be treated with a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal of consent. Clinical endpoints will include adverse experiences, progression-free survival (PFS) and response rate (RR). SAMPLE:Patients must have a histologically confirmed diagnosis of epithelial ovarian cancer, cancer of the Fallopian tube or primary peritoneal adenocarcinoma. All patients will have received first-line therapy with carboplatin plus paclitaxel. Patients should be platinum sensitive, defined as recurrence or progression of ovarian cancer, cancer of the Fallopian tubes or primary peritoneal adenocarcinoma 6 months or later after the end of first-line chemotherapy. Patients to be enrolled on this study must have acceptable performance status and acceptable renal and hepatic function, and be free of other serious intercurrent illness that could impair their ability to receive protocol therapy. The study will include up to 55 assessable patients, of which 20 will provide biomarkers. It is estimated that the inclusion period will last approximately 24 months. DOSAGE/DOSAGE FORM, ROUTE, AND DOSE REGIMEN Eligible patients will be treated with paclitaxel (175 mg/m2) and carboplatin AUC5 administered by intravenous infusion (IV) on day 1 of each treatment cycle. In addition, all eligible patients will receive treatment with oral vorinostat (400 mg) administered once daily by mouth with food on days -4 through 10 of Cycle 1 (25-day treatment cycle) and days 1 through 14 of each subsequent 21-day treatment cycle. Patients will receive antiemetic therapy according to institutional guidelines as well as premedication with dexamethasone, and antihistamines (an H1-receptor antagonist and an H2-receptor antagonist) for prevention of the side effects of paclitaxel.

Condition Intervention Phase
Ovarian Cancer
Drug: Paclitaxel, Carboplatin and Vorinostat
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Non-Comparative Study of Paclitaxel Plus Carboplatin in Combination With Vorinostat in Patient With Advanced, Recurrent, Epithelial Ovarian Cancer

lindaprocopio's picture
lindaprocopio
Posts: 2022
Joined: Oct 2008

I am actually afraid of early phase trials, but if this is a later phase trial then they may be getting closer to showing something new that works. I've never heard of Vorinostat before, so put it on my list of things to ask my chemo oncologist.

I wonder about my 'single agent' weekly taxol, even though I double-checked the NCCN guidelines and that is certainly one of the most recent recommended protocols for UPSC recurrance. But the NCCN Guidelines sounded so discouraged about UPSC recurrance, and their recommendations were largely based on 'quality of life' factors and toxicity, suggesting 'additional clinical trials needed' as life expectancy/prognosis, regardless of treatment options, was grim for UPSC recurrance. The NCCN recommended treatment options for UPSC recurrance clearly didn't have a CURE as a goal, and didn't even seem optimistic about achieving any kind of prolonged remission. Instead the goal was to slow the progression of the disease and the discomfort of the progression. No one uses the term 'palliative care' with me, instead calling it 'managing the disease'.

Ah, well. The weekly taxol is dropping my CA-125, so as long as that continues, I will stick with the current chemo program. Here are my current physical symptoms:

1.) My bowels continue to be a mess whenever I venture off of my low-residue diet to try and reintroduce fiber of any kind (blamed on the pelvic radiation).
2.) And at the end of the day, my mid-section feels like I have done too many sit-ups, that same dull ache in my torso when I move that I used to get from exercising my stomach muscles on the Roman Chair at the gym. (only I am not exercising!)
3.) About once a week I notice that my pelvic mound swells a little with what I think is some kind of fluid in that region (blamed on the lymphodema as my 1 ankle also swells once in awhile).

I will be afraid when I have my CT-scan in early February, as none of the lymph nodes they found enlarged with my PET-scan in November were in places that would cause bowel issues or around my front rib cage where this daily new dull 'muscle(?)' ache is, or in the front of my pelvis where the swelling occurs. But I want the CT-scan since I could be wrong about what I fear, and my CT-scan COULD show the lymph nodes shrinking and no cancer progression, and then I would get a break from chemo. I'll keep you posted.

california_artist's picture
california_artist
Posts: 860
Joined: Jan 2009

I am unfortunatly in a pissy mood this morning, but I think what I posted about taxol and turmeric being used together getting a much more positive response than either alone on the thread Mary Ann posted this morning might be of help to you. I mention the ER/PR- because the breast cancer, which is an advanced recurrence in the study I read, was most effected by the combination if the cells were ER/PR negative, which UPSC normally is. It may be if you take the results of the study to one of your doctor's appointments and make it part of your file that he will be more likely to look into it and use the protocol for you. I think once they give you a timeline for death, they can try all sorts of things to make that not true, as can you.

Have you had a chance to start reading that book now that the holidays are over. I really think it could change things for you.

In love, caring and full out nagging,

Claudia

lindaprocopio's picture
lindaprocopio
Posts: 2022
Joined: Oct 2008

I can see you are frustrated that I am not following up on your suggestions which I KNOW are out of love and caring. But I have to stay on this low-residue diet or my body simply won't absorb any nutrition from anything I eat. I keep trying to introduce some fresh fruis, veggies, grains, nuts,...and ALL of that stuff runs right through me (looks exactly the same coming out as going in, totally undigested, and in and out within the hour! TMI, sorry.) I actually would feel better to just drink Boost and not even try and eat even that bland diet the nutritionist prescribed, although I force myself to eat at least twice daily. I can only imagine what tumeric would do to inflame my bowels if I start adding it to my food, as much as I love the taste of it.

Recurrance is a whole new ball game. Endurance is the issue now, and balance. I don't plan to be a quitter, but I no longer see the up side in heroics either. Maybe I'm in a strange mood myself, as I am taking down my Christmas tree today. And this year, I am packing the 'family heirloom' ornaments in a special box for the grandchildren. Hopefully I will still be here to unpack and hang them on my December 2010 tree, but just the act of adding them to 'the kid's box' gives you a glimpse into my thinking today.

california_artist's picture
california_artist
Posts: 860
Joined: Jan 2009

diet part mostly. That book is actually about many things other than diet, so there are other things that might help you too. It's also about exercise, relaxation, and host of other things that certainly the title give one no clue about. It should have been titled oodles of fun things you can do right now that don't cost anything that keep you from dying from cancer or at least make you live waaaaaaaaaaay longer just like I did.
Wonder why he didn't call it that???

That's why I didn't understand your reluctance, it was the diet thing. While I knew it wasn't only diet, how could you? Ever so sorry.You'll get to it when you're ready. Right now you're going through an adjustment period, trying to find your path to a new way of thinking. You will.

claudia

Are you allowed to use something by Metamucil called Clear and natural or words to that effect. My sister who has really bad intestine problems, started using this and she feels much better. It helps to heal the absorption problem some people have.

This year I didn't even put up a tree or do any decorations. I think next year will be a go though, this Christmas, not so much.

Glad you're planning ahead, let's me know you're calmly considering your options.

So very sorry to hear of the bowel issues. That must just be horrible. Are you able to find anything that sticks? Do they think it's from the current chemo regimen or do you feel it's left over from the radiation you had before. Will it get better soon do you think? Taxol is one of the older, safer drugs, so here's to thoughts of things not getter worse only better. I'll stop suggesting things.

I can't truly imagine the things you're going through just now.

According to my doctor, I should be dead now. It's quite possible that this constant hopeful search for answers has kept me alive, up til now anyway. Wonder what's going to happen in the next few weeks when I quit searching and just live my life. There'a question.
Apparently, they don't always know what they're talking about. You must feel so ah, blind sided by the recurrence since you had been put onto the train to future wellness, and have somehow been unloaded on the recurrence platform. They are working on the train that takes you back and deposits you again on that train to wellness. Stay well as you are able til it comes back to pick you up.

Don't let them put you on the wrong train again. Read the destination sign very, very, very, carefully. You know best, you'll find your way through this and enjoy next Christmas with the grand children. Think of the fun you'll all have unpacking that box.

With love and caring, and a promise of no future nagging,

your friend,

Claudia

Ro10's picture
Ro10
Posts: 1481
Joined: Jan 2009

I had not heard of the new drug you listed in your above post. I too will keep note of that when I see my onocologist in February. I don't know if I will meet the criteria of being 6 months post treatment, if my CAT scan shows any evidence of disease. I am hoping the CAT scan will be clear.

I am sorry to hear you will signing off regular posting, as you have done so much research. I do appreciate all your hard work and sharing the information with all of us.

Wishing you luck with your "moods" and your finances. Hope 2010 is a better year for you. In peace and caring.

TiggersDoBounce's picture
TiggersDoBounce
Posts: 413
Joined: Oct 2009

Linda,

"My bowels continue to be a mess whenever I venture off of my low-residue diet to try and reintroduce fiber of any kind (blamed on the pelvic radiation)."

How long post radiation are you? This Bowel thing is really making me nuts....I need some light on the horizon!

Laurie

Ro10's picture
Ro10
Posts: 1481
Joined: Jan 2009

I am so happy that the weekly taxol continues to work for you. I am so sorry about all of your physical symptoms. It must be terrible to still have your bowels "a mess." I know how healthy you ate before all of this. Not being able to have any fruits and vegetables has to be very hard for you.
During my first chemo treatment, I experienced abdominal and back discomfort. The chemo nurse told me that was the chemo working. She said that is a common reaction. Maybe because you are getting chemo every week it is effecting your abdomen. I would think the bowel problems could make the abdomen not feel good either.
I know when I got the Neupogen shots in the hospital I had a lot of abdominal and back spasms. Maybe the daily neupogen shots are effecting your abdomen, too. I hope that those are reasons for your abdominal discomfort. When I got the Neulasta shots, the discomfort was more like deep bone pain.
When I was first diagnosed my gyn/onocologist told me that the UPSC was highly aggressive and most likely to reoccur. He said that it is sometimes treated as "a chronic condition." He never mentioned, cure, but treatable.
You remain in my prayers. I hope your CAT scan in February is much improved, so you can get a break from the chemo and let your body recover. In peace and caring.

Songflower's picture
Songflower
Posts: 632
Joined: Apr 2009

When I was on carbo/taxol I always got a sore abdomen. My Gyn Onc said it was from the cell kill, the chemo also takes out some good cells and it hurts. For the first few rounds I endured it but as time went on when it was worsening I took two pain pills at night just to get it under control and sleep. It would also hurt under my ribs. I think it is chemo related as I don't have it now and have been off chemo since July.

Diane

Gunhild's picture
Gunhild
Posts: 37
Joined: Jul 2009

Linda, just thought I would share with you that I have many of the same abdominal symptoms that you describe - especially the diarrhea and achy abdomen. I feel like someone hit me in the belly with a 2X4 yesterday. I didn't have these problems before I had brachytherapy. I ended up with a huge ventral hernia after the initial surgery and at first thought that was causing some of my problems. I have to wear a binder most of the time. I don't feel this is a recurrence. I hate the diarrhea and having to get to the bathroom quickly when I need it. Our trip from NY to Florida was an experience to say the least.

Keep the faith. Chris

Ro10's picture
Ro10
Posts: 1481
Joined: Jan 2009

Wow is it expensive. From what I could find, the treatment is 4 capsules a day with the cost of $60 a capsule. One site listed the cost of a bottle of 120 capsules at $7200 and another site said the monthly treatment would be $8640. What I could find it used for was skin cancer and leukemia. So I am sure insurance would not cover it for UPSC. Who could afford to pay for it????????

california_artist's picture
california_artist
Posts: 860
Joined: Jan 2009

Yeah, about the mood thing, ah, sorry.

About the drug thing, most manufacturers will pay for the drug if you have a financial need and make under a certain income cap. It's quite high, $l00,000, for some companies. Since you have had you obligatory chemo and radiation and had a recurrence or it was not effective, you usually qualify for off label treatment.

I have started to pull way back. Thought it odd almost no one posted yesterday.

Feel the fight in you.

claudia

I finished reading the book. The ideas are ones, some of them anyway, that I will put into action over the next few weeks. I was greatly inspired by the information on exercise and meditation,neither of which I've paid much attention to in the past. Sorta quit exercising when the bike got stollen. I now wonder if the many, many rides I took in the first year after diagnosis didn't greatly help me get to this point.

Rewriter's picture
Rewriter
Posts: 496
Joined: Dec 2009

I am also trying to implement lots of the recommendations in the Anticancer book, particularly those having to do with exercise. Generally, if you have a YMCA in your area, they give financial assistance to people unable to pay the regular fee. I pay $25. a month, but there are free memberships given to those who qualify--and having or having had cancer is high on their list of qualifying conditions. Anyway, I have been going to the gym, walking on the treadmill and lifting some weights; and sometimes when I get a new muscle I'm frightened that it is a huge tumor. I guess I have been out of shape.

I'm adding lots of ginger and turmeric to my food. Sweet potatoes and carrots are great steamed, mashed, and then laced with raw ginger. Turmeric is fantastic with cous cous, and all of these dishes are easy and cheap to prepare.

Yesterday, I found an apartment that I think I can afford. Today, I hope to sign the lease. It's in a Brooklyn brownstone and has space for my big farm table, which is critical to my strong desire to have my place be a communal dining room. Anyway, I have been living in a bad situation--with a friend whom I needed to "take care" of me but who ended up being really resentful--but have been afraid to take the steps necessary to reclaim my life. I had a one-year checkup; and so far, so good. Maybe I can visualize myself completely healthy, keep making all those important food, exercise, and meditation changes, and focus on my passions.

I wish all good things for everyone here. Happy new year.

Love,

Jill

kkstef's picture
kkstef
Posts: 706
Joined: May 2008

Hi Jill,

It sounds like you are off to a good start in 2010. Am so happy for you that have taken some steps to free yourself from a difficult situation!

I like hearing new ideas about ways to use ginger and tumeric. I just can't chomp on raw ginger and enjoy it!!

Yup....exercise is good for all of us! I am going to kick mine up a notch this year. And there are lots of exercises that are relatively inexpensive: walking briskly (although it is only 5 degrees here this a.m. and a foot of snow so that doesn't sound like a good option), jump rope, hand weights, stretch bands and an exercise ball. The library has lots of good DVD's on various exercises. I have been known to check one out and then SIT and watch it! :-)

And I am going to take Mary Ann and Diane's advice and try some guided imagery and meditation.

Hoping for a wonderful 2010 for everyone!!!

Karen

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