Amgen halts clinical trial combining chemotherapy with Avastin and Vectibix

Amgen has discontinued the PACCE clinical trial which was evaluating adding Vectibix® (panitumumab) to standard first-line treatment for metastatic colorectal cancer.  The PACCE trial randomly assigned patients to receive chemotherapy and Avastin®(bevacizumab) or chemotherapy plus both Avastin® and Vectibix®.

An early analysis built into the trial showed that patients in the standard therapy control arm had better progression-free survival that those in the experimental arm that included Vectibix.  Further analysis also showed better overall survival for the control arm.  Additional study of the trial is underway, and Amgen plans to present the information at an upcoming scientific meeting.

Amgen has let research physicians whose patients are enrolled in the PACCE trial know that Vectibix should be discontinued for those in the experimental arm of the study.  Patients will have the option of continuing the study on chemotherapy and Avastin alone.

In January 2007, Amgen reported an interim safety analysis of the trial that showed increased diarrhea, dehydration, and infection for those patients whose treatment plan included Vectibix.  There were also more cases of blood clots in the lungs (pulmonary embolism) in the Vectibix arm — 4 percent versus 2 percent.  One patient receiving Vectibix died of pulmonary embolism.

Roger M. Perlmutter, M.D. Ph.D., executive vice president of Research and Development at Amgen said,

Patient safety is Amgen’s top priority. For this reason, we have decided to discontinue Vectibix treatment in the PACCE trial while we complete additional analyses of these preliminary results. We had hoped that adding Vectibix to the current U.S. standard-of-care for patients newly-diagnosed with metastatic colorectal cancer would improve outcomes without excessive added toxicity. Unfortunately, it appears that adding Vectibix to Avastin, when used in combination with oxaliplatin- or irinotecan-based chemotherapy, increased toxicity, without improving efficacy.

Vectibix is a monoclonal antibody which blocks the epidermal growth factor.  It is currently approved by the FDA to treat patients whose colon or rectal cancer has progressed on standard treatments.  Compared to the best supportive therapy, Vectibix, as a single drug, increased the time that cancer did not progress.

Amgen will continue enrolling patients in trials where Vectibix is the only monoclonal antibody added to chemotherapy including:

• Phase III study to compare FOLFIRI with Vectibix to FOLFIRI alone for second-line treatment of metastatic colorectal cancer.
• PRIME: Phase III study comparing FOLFOX with Vectibix to FOLFOX alone for first-line treatment of metastatic colorectal cancer.

WHAT THIS MEANS FOR PATIENTS

Combining chemotherapy and Avastin with Vectibix led to poorer outcomes for patients having their first treatment for stage IV or recurrent colon or rectal cancer (metastatic colorectal cancer.)

Patients on who received Vectibix in addition to chemo with Avastin had their cancer get worse more quickly (progression-free survival) and also had shorter survival time (overall survival).

Earlier analysis of side effects found that including Vectibix increased serious diarrhea, dehydration, infection, and blood clots in the lungs.

Overall, adding Vectibix to standard chemotherapy with FOLFOX or FOLFIRI plus Avastin resulted in more toxicity and less effectiveness.

Patients who are part of the PACCE trial should stop using Vectibix if they are on the experimental arm of the trial.  They can continue the trial with chemotherapy and Avastin alone.

Vectibix is not labeled for use with Avastin and chemotherapy.  It is labeled to be used alone (as monotherapy) for refractory patients who have progressed on standard therapy. Its use for treatments other than those that are currently FDA-labeled should be limited to clinical trials.

We have no information from this trial about whether a similar EGFR inhibitor, Erbitux® (cetuximab), would have similar outcomes.

Disclosure: C3 has accepted funding for projects and educational programs from Amgen in the form of unrestricted educational grants. C3 has ultimate authority over website content.

Posted by Kate Murphy on March 27th, 2007
Posted in: Research & Treatment News | No Comments »

White House Press Secretary Tony Snow has recurrence of colon cancer

During surgery on March 26 to remove a small growth in his pelvis, doctors found that the growth was cancerous and that Tony Snow’s colon cancer had spread to his liver.  He will likely be undergoing chemotherapy after he leaves the hospital.  Snow, the White House Press Secretary, was first diagnosed with colon cancer in 2005.

Doctors have been monitoring the pelvic growth since September.

On Friday, Snow told the White House press corps:

Please do not leap to conclusions about this because we don’t know what this is. We know it’s coming out and I know I’ll be back soon.

President George Bush spoke about Snow’s condition in the Rose Garden this morning:

THE PRESIDENT: This morning I got a phone call from Tony Snow. He called me from the hospital. He told me that when they went in and operated on him they found cancer. It’s a recurrence of the cancer that he thought that he had successfully dealt with in the past. His attitude is, one, that he is not going to let this whip him, and he’s upbeat. My attitude is, is that we need to pray for him, and for his family.

Posted by Kate Murphy on March 27th, 2007
Posted in: Research & Treatment News | 2 Comments »

Senators Specter (R-PA) and Harkin (D-IA) Offer Amendment to Increase Cancer Funding - TAKE ACTION NOW

Senator Specter (R-PA) and Senator Harkin (D-IA) offered a Budget Amendment on Wednesday proposing a $2.2 billion increase for health programs in America. A vote is expected as early as Friday, March 23rd.

WE MUST ACT TODAY!!

This Amendment will help to secure funds for cancer research at the National Institutes of Health (NIH) and for cancer programs at the Centers for Disease Control and Prevention (CDC), including the Colorectal Cancer Screening, Education, and Outreach Initiative.

Please contact your Senators RIGHT NOW and urge them to vote in favor of this amendment.

Follow this link to email your Senators directly through our website.

Posted by Joe Arite on March 22nd, 2007
Posted in: Policy & Advocacy News | 1 Comment »

The Group Room Cancer Talk Radio

Colorectal Cancer Awareness Month

A Continued Discussion

The Group Room Cancer Radio Talk Show

Sunday, March 25, 2007    4 - 6 p.m. Eastern

CALL IN at 1-800-GRP-ROOM • (1-800-477-7666)

The Group Room will continue its focus on Colorectal Cancer Awareness Month with a discussion of advances in treatment, research, and clinical trials from a US and German perspective.  Selma Schimmel hosts the show.

Featuring

Prof. Heinz-Josef Lenz, MD
Professor of Medicine, Director, GI Oncology Program, Scientific Director,
Cancer Genetics, USC Keck School of Medicine, USC/Norris
Comprehensive Cancer Center, Los Angeles, CA

Prof. Peter Hohenberger, MD
Head, Division of Surgical Oncology & Thoracic Surgery Department of
Surgery, Klinikum Mannheim, University of Heidelberg, Theodor Kutzer
Ufer Mannheim, Germany

To hear the broadcast:

• List of local stations broadcasting The Group Room.
• Listen to The Group Room on the web
• Listen live via XM Satellite Radio on  TalkRadio Channel 165
• Download a Podcast from iTunes or iRadioNow.com

Vital Options International is pleased to partner with
C3: Colorectal Cancer Coalition for this broadcast

Posted by Kate Murphy on March 21st, 2007
Posted in: Research & Treatment News | No Comments »

C-reactive protein levels predict survival after surgery to remove liver mets from colorectal cancer

Patients who were having surgery to remove colon or rectal cancer that had spread to their liver had poorer outcomes if their C-reactive protein level was high prior to surgery. C-reactive protein (CRP) in the blood is a measure of inflammation in the body. 

Researchers in the United Kingdom measured CRP the day before surgery for 171 patients who were about to have liver tumors removed with the goal of curing their cancer.

Median survival time after surgery for patients with an elevated CRP was 19 months while those patients who had a normal level was 43 months.  Patients with a high CRP also had their cancer return sooner,  Median disease-free survival w12 months versus 15 months for those with normal CRP.

V.K.H. Wong and colleagues at St. James Hospital in Leeds concluded:

The result of the study showed that an elevated preoperative CRP is a predictor of poor outcome in patients undergoing curative resection for colorectal liver metastases.

SOURCE:  V.K.H. Wong et al, British Journal of Cancer (2007) 96, 222-225

Posted by Kate Murphy on March 18th, 2007
Posted in: Research & Treatment News | No Comments »