Clincal Trial - Cetuixmab

Fighting4Popi

Hello -- My dad (58 years old) was recently diagnosed with esophageal cancer. T3N1. So far we've had a EUS, cat scan and PET scan and are waiting on the PET scan results to confirm that the cancer is localized in this area. We were offered participation in a phase III clinical trial that adds Cetuximab with the chemo/radiation treatment. This is all pre-surgery.

Does anyone have any experience or have participated in a clinical trial?

Thank you and god bless!!

Unknown

This comment has been removed by the Moderator

unclaw2002

Hi,
Yes several folks on
Hi,

Yes several folks on this board have received Cetuximab (also known as Erbitux) in various clinical trials. It is considered one of the new group of drugs that targets the tumor. It seems that if your tumor is tested and has an epidermal growth factor receptor (EGFR)-expressing, KRAS factor then the Cetuximab/Erbitux seems to be more effective. It has already been FDA approved for colon and squamous cell carcinoma of the head and neck. Many of the drugs being used on EC were first approved for colon cancer.

For my dad he was Stage IV and was on a clinical trial of Irinotican and Erbitux. The chemo worked and stabalized the cancer, but unfortunately other complications set in. For Stage IV patients the Erbitux will eventually stop working because the tumors are smart and figure a work around to the drug. But for a Stage III patient who can have surgery the Erbitux has proved to improve the chances of attacking the tumor and destroying a significant amount of the tumor prior to surgery and a successful recovery. The Stage III trials seem to include at least 2 other chemo drugs in addition to the Erbitux.

Good luck - let us know where your dad is being treated and also your name. We are like a family here even though we may never meet.

Best wishes,
Cindy

Fighting4Popi

unknown said:

This comment has been removed by the Moderator

My dad was diagnosed on
My dad was diagnosed on November 10, 2011 and we currently live in Michigan. We are at Karmanos in Detroit Michigan and the following are our doctors:
Oncologist = Dr Choi
Radiation Oncologist = Dr Andre Konski
Thoracic Surgeon - Dr Alvelo-Rivera

We were originally at St Johns Hospital in Detroit and then after research we basically self-referred ourselves to Karmanos. We have not had any second opinions. My dad felt comfortable at Karmanos and we wanted to get moving on the treatment. I know we are taking a chance but I figured that the team structure that they follow at Karmanos meant that many doctors would be looking at my dad's scans and results.

We do not know exactly yet what Chemo we will be receiving but if we participate in the clinical trial then we will have the paclitaxel / cisplatin. He is also schedule for 28 days of radiation.

btw -- I am Lori

Unknown

Fighting4Popi said:

My dad was diagnosed on
My dad was diagnosed on November 10, 2011 and we currently live in Michigan. We are at Karmanos in Detroit Michigan and the following are our doctors:
Oncologist = Dr Choi
Radiation Oncologist = Dr Andre Konski
Thoracic Surgeon - Dr Alvelo-Rivera

We were originally at St Johns Hospital in Detroit and then after research we basically self-referred ourselves to Karmanos. We have not had any second opinions. My dad felt comfortable at Karmanos and we wanted to get moving on the treatment. I know we are taking a chance but I figured that the team structure that they follow at Karmanos meant that many doctors would be looking at my dad's scans and results.

We do not know exactly yet what Chemo we will be receiving but if we participate in the clinical trial then we will have the paclitaxel / cisplatin. He is also schedule for 28 days of radiation.

btw -- I am Lori

This comment has been removed by the Moderator

AngieD

unclaw2002 said:

Hi,
Yes several folks on
Hi,

Yes several folks on this board have received Cetuximab (also known as Erbitux) in various clinical trials. It is considered one of the new group of drugs that targets the tumor. It seems that if your tumor is tested and has an epidermal growth factor receptor (EGFR)-expressing, KRAS factor then the Cetuximab/Erbitux seems to be more effective. It has already been FDA approved for colon and squamous cell carcinoma of the head and neck. Many of the drugs being used on EC were first approved for colon cancer.

For my dad he was Stage IV and was on a clinical trial of Irinotican and Erbitux. The chemo worked and stabalized the cancer, but unfortunately other complications set in. For Stage IV patients the Erbitux will eventually stop working because the tumors are smart and figure a work around to the drug. But for a Stage III patient who can have surgery the Erbitux has proved to improve the chances of attacking the tumor and destroying a significant amount of the tumor prior to surgery and a successful recovery. The Stage III trials seem to include at least 2 other chemo drugs in addition to the Erbitux.

Good luck - let us know where your dad is being treated and also your name. We are like a family here even though we may never meet.

Best wishes,
Cindy

Allergies to it
I was sent an email today from NCCN.com. While surfing around their site, I found this.
Angie


Erbitux Allergies Print E-mail

Cancer patients from the Southeastern United States who are treated with the drug cetuximab, known commercially as Erbitux, are far more likely to suffer severe allergic reactions than patients in other regions of the country. Now researchers from Vanderbilt-Ingram Cancer Center have discovered an underlying clue to this mystery. It appears many of those patients already have a pre-existing antibody that reacts with the cancer drug, causing severe allergic reaction. Christine Chung, MD, assistant professor of Medicine and Cancer Biology at Vanderbilt-Ingram Cancer Center is the lead author of the study published in the New England Journal of Medicine.

Cetuximab is a monoclonal antibody approved for use in colon cancer and squamous-cell head and neck cancer. Dr. Chung became curious about the drug when several Vanderbilt-Ingram patients had severe allergic reactions shortly after being infused with the substance. Some of the reactions were life-threatening.

“When I saw my patients having these allergic reactions they looked very much like the anaphylactic reaction in its acuity and symptom presentation as you see with something like severe peanut allergy,” said Dr. Chung. “The anaphylactic reactions are triggered by immunoglobulin E or IgE. Patients must be exposed to a substance, or antigen, before the body becomes sensitized to it and generates IgE. But these cancer patients had never been exposed to the drug cetuximab."

“I thought there must be pre-existing IgE antibodies in these patients from an antigen that is similar to cetuximab and that’s why people are having reactions,” explained Dr. Chung. “While talking to other physicians, we noticed that we were seeing these reactions more frequently in the Southeast.”

Higher rates have been reported in Tennessee, North Carolina, Arkansas, Missouri and Virginia. By contrast, less than one percent of patients had such reactions in the Northeast.

Dr. Chung joined forces with Vanderbilt-Ingram researchers Jordan Berlin, MD, Emily Chan, MD, PhD, Barbara Murphy, MD, and Robert Slebos, PhD. They contacted colleagues at the University of Virginia, Stanford, Duke, Harvard and the Allergy and Asthma Clinic of Northwest Arkansas, along with Bristol-Myers Squibb and ImClone Systems, the drug’s manufacturers. The group pooled serum samples from cancer patients, as well as control subjects. Then they tested the samples for the IgE antibody.

Among 76 cetuximab-treated subjects, 25 had a hypersensitivity reaction. Antibodies against cetuximab were found in pretreatment samples from 17 of these subjects. Only one of 51 subjects who did not have a reaction had the antibodies.

The geographic differences were striking. The antibodies were found in 20.8 percent of samples from control subjects in Tennessee, 6.1 percent of samples from northern California and 0.6 percent from Boston.

Next the researchers had to figure out what the antibodies were binding to in the drug. After ruling out several options, they found the smoking gun – sugar molecules that are added to the protein during the process of making the drug in a cell line.

Dr. Chung said the finding is significant because it was the first study to show that IgE antibody can be made against sugar molecules commonly present on proteins. Now manufacturers can avoid using that cell line to create antibody-based drugs to prevent such reactions. Based on this research, a commercial assay is being developed to allow physicians to test patients for the troubling antibody before deciding to use the drug.

But another mystery still remains. What is the triggering antigen that Southerners are exposed to that causes this allergic reaction?

“I have a hunch that it might be an infectious organism, perhaps something that is more common in warm, humid weather,” Chung mused.

The scientists already have a list of possible culprits, including histoplasmosis, amoebas or other parasitic infections.

by Dagny Stuart

Fighting4Popi

unknown said:

This comment has been removed by the Moderator

Thank you for offering to
Thank you for offering to speak with my dad. I will share that offer with him.

We had the PET results shared with us yesterday and they did not see cancer anywhere else other than the esophagus and lymph node. Good news for Popi!!! He had his port installed today and doesn't seem to be a bother yet. Treatment plans are being finalized but we are ready to take on this battle.

Thanks again for sharing your story....it's comforting knowing that we have a chance to beat this.

Fighting4Popi

unclaw2002 said:

Hi,
Yes several folks on
Hi,

Yes several folks on this board have received Cetuximab (also known as Erbitux) in various clinical trials. It is considered one of the new group of drugs that targets the tumor. It seems that if your tumor is tested and has an epidermal growth factor receptor (EGFR)-expressing, KRAS factor then the Cetuximab/Erbitux seems to be more effective. It has already been FDA approved for colon and squamous cell carcinoma of the head and neck. Many of the drugs being used on EC were first approved for colon cancer.

For my dad he was Stage IV and was on a clinical trial of Irinotican and Erbitux. The chemo worked and stabalized the cancer, but unfortunately other complications set in. For Stage IV patients the Erbitux will eventually stop working because the tumors are smart and figure a work around to the drug. But for a Stage III patient who can have surgery the Erbitux has proved to improve the chances of attacking the tumor and destroying a significant amount of the tumor prior to surgery and a successful recovery. The Stage III trials seem to include at least 2 other chemo drugs in addition to the Erbitux.

Good luck - let us know where your dad is being treated and also your name. We are like a family here even though we may never meet.

Best wishes,
Cindy

Hello Cindy --
My name is
Hello Cindy --
My name is Lori and my dad is participating in this Phase III clinical trial using cetuximab. He will be receiving cisplatin and paclitaxel. These along with radiation will all begin tomorrow. We are being treated at Karmanos in Detroit, Michigan.

Scared for what the next few months will bring but hoping for the best.

Prayers.....
Lori

unclaw2002

Fighting4Popi said:

Hello Cindy --
My name is
Hello Cindy --
My name is Lori and my dad is participating in this Phase III clinical trial using cetuximab. He will be receiving cisplatin and paclitaxel. These along with radiation will all begin tomorrow. We are being treated at Karmanos in Detroit, Michigan.

Scared for what the next few months will bring but hoping for the best.

Prayers.....
Lori

Lori,
Good luck. Make sure
Lori,

Good luck. Make sure he keeps hydrated. Also, keep some benedryl on hand for itching from the ERbitux. They will give him the antihistimines when they are administering the erbitux it takes a while the first time because they will montinor him closely for any potential allergic reaction. Most people do fine but I would make sure someone is with him especially during his first chemo treatment.

Hydration is key because the patient really can't drink enough by mouth to keep enough liquids in them --- perhaps some extra IV fluids would be helpful. Don't be afraid to ask. And remember that the chemo builds up so he may only have mild symptoms at first, or he may be one of the lucky ones that sails straight through chemo. Is your dad a candidate for surgery?

Best,
Cindy

oriontj

unclaw2002 said:

Lori,
Good luck. Make sure
Lori,

Good luck. Make sure he keeps hydrated. Also, keep some benedryl on hand for itching from the ERbitux. They will give him the antihistimines when they are administering the erbitux it takes a while the first time because they will montinor him closely for any potential allergic reaction. Most people do fine but I would make sure someone is with him especially during his first chemo treatment.

Hydration is key because the patient really can't drink enough by mouth to keep enough liquids in them --- perhaps some extra IV fluids would be helpful. Don't be afraid to ask. And remember that the chemo builds up so he may only have mild symptoms at first, or he may be one of the lucky ones that sails straight through chemo. Is your dad a candidate for surgery?

Best,
Cindy

My husband had erbitux..staged III clinlical trial
He only had a reaction to it the first time..they slowed down the IV and no problems after that. He had it cisplation, taxol and radiation. It kept him cancer free for a year, it came back at the original site. One lymph node was involved and it killed the cancer in that one but still no surgery. He's back on chemo..and is doing ok so far.

In this trial, it was a random draw whether or not he would get it. He was told he would receive it and did. No double blind in a phasee III trial. Either you get or you don't.

He personally thinks it had a lot to do with his being cancer free so long.

jan

Fighting4Popi

oriontj said:

My husband had erbitux..staged III clinlical trial
He only had a reaction to it the first time..they slowed down the IV and no problems after that. He had it cisplation, taxol and radiation. It kept him cancer free for a year, it came back at the original site. One lymph node was involved and it killed the cancer in that one but still no surgery. He's back on chemo..and is doing ok so far.

In this trial, it was a random draw whether or not he would get it. He was told he would receive it and did. No double blind in a phasee III trial. Either you get or you don't.

He personally thinks it had a lot to do with his being cancer free so long.

jan

Hi Jan - Popi's first
Hi Jan - Popi's first treatment went really well. He did not have any reactions to the cetuximab, cisplatin, taxol or radiation. We are continuing radiation every day.

We are planning on having surgery after this treatment.

cher76

Fighting4Popi said:

Hi Jan - Popi's first
Hi Jan - Popi's first treatment went really well. He did not have any reactions to the cetuximab, cisplatin, taxol or radiation. We are continuing radiation every day.

We are planning on having surgery after this treatment.

Erbitux
My husband was on Erbitux and Irinotecan for 7 month. During that time his tumors shrunk considerably as well as the places where the cancer had metastisized to. He was taking it every three weeks from March to September, and it was after that time that the cancer began to grow again. The side effects from the Erbitux were not that bad. It does effect your skin though, and we were told to use CeraVe lotion and soap, or something similar to help with the skin conditions. Also he was prescribed a medication that we would dab on the acne type pimples that would pop up all over. He also recevied Neulasta monthly as well as Sandostatin. Being a Stage IV, I really believe that the Erbitux helped my husband.
Cheryl
Wife of Rickie, dx Stage IV EC, Oct. 2010
mets to bones and brain