Patient support to locate and enroll in colorectal cancer clinical trials

Advocates offer help to colorectal cancer patients and their families to locate cancer clinical trials, get enrolled, and complete studies to find new treatments and prevention strategies.

Although patients may benefit from participation in a clinical trial and the clinical trial system is critical to developing new and better treatments for colorectal cancer, many people don’t understand the system or know that they might be eligible for a trial.  Fewer than 5% of adults find cancer treatment in a clinical trial.  New initiatives are underway to provide information about clinical trials, help patients locate the right trial, and give support to trial participants.

Information about cancer clinical trials

• C3 — Colorectal Cancer Coalition provides online information about cancer clinical trials with links to NCI and FDA web sites, along with questions to ask the doctor about clinical trials.
• The Coalition of Cancer Cooperative Groups has additional information about  cancer clinical trials and the cooperative group system on its web site  Cancer Trials Help   The Coalition has also published Knowledge Is Power: A Patient’s Guide to Cancer Clinical Trials, available as a PDF download.

Locating the right trial

• The Coalition of Cancer Cooperative Groups developed QuickLink to help people find and enroll in key colorectal clinical trials.  The 10 colorectal cancer trials listed in QuickLink were identified as priority research by the Scientific Leadership Council in Gastrointestinal Cancer with input from colorectal oncology researchers, cancer cooperative groups, patient advocates, and representatives of the pharmaceutical industry.  Additional trials can be found using the Coalition’s TrialCheck program.
• C3 provides a free and confidential clinical trials matching service in collaboration with EmergingMed.  Patients can narrow their search for an appropriate trial through an online interview and can receive individual assistance in choosing potential trials to discuss with their doctors by calling EmergingMed at 1–866–278–0392. If requested, Customer Service Specialists at Emerging Med will make trial contacts for patients and facilitate enrollment.

Peer support for clinical trial participation

• The Colon Cancer Alliance has recently announced an expansion of their Buddy Program to provide experienced peer mentors to help newly diagnosed patients understand and negotiate the clinical trials system.  Patients who would like to have a buddy assigned can request one at the CCA web site or call  1-877-422-2030

In Knowledge is Power Dr. Norman Wolmark, Chair of the National Surgical Breast and Bowel Project (NSABP), points out the advantage to patients of studying available clinical trial information even if they decide not to participate.

“Clinical trials require a consensus as to what should represent the standard of care.  So even if patients choose not to participate in the trial, by reviewing the material, they would understand what comprises state-of-the-art care.  The choice is an empowerment.  If people knew about clinical trials, I think they would understand their disease better.”

Posted by Kate Murphy on February 28th, 2006
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Xaliproden reduces severe peripheral neuropathy associated with oxaliplatin

Patients with metastatic colorectal cancer who received xaliproden during treatment with oxaliplatin (FOLFOX4) had less severe peripheral neuropathy than patients randomly assigned to a placebo.  Xaliproden reduced the risk of severe (grade 3) peripheral neuropathy by about 40%.  There was no difference in chemotherapy effectiveness between the two groups.

Results of the Xenox study, which randomly assigned patients receiving first-line treatment FOLFOX for metastatic cancer, to xaliproden or placebo, were reported at the 2006 GI Symposium in San Francisco. James Cassidy M.D., the principal investigator for the study, discussed the research during the meeting.  An audio recording of his presentation, along with slides, is available online in the ASCO virtual meeting. 

Peripheral neuropathy — tingling, numbness, pain, and difficulty using the hands and feet — limits the amount of oxaliplatin treatment that patients with colorectal cancer can tolerate.  The effect is cumulative, with about 20% of patients experiencing severe neuropathy that interferes with their activities of daily living by the time they have received 1000 mg of oxaliplatin. 

In the Xenox trial, patients who were receiving FOLFOX chemotherapy began receiving either a daily oral 1 mg dose of xaliproden with their first FOLFOX treatment or a placebo.  Xaliproden continued until 15 days after the last oxaliplatin treatment.

Almost three quarters of all patients had some degree of peripheral neuropathy during treatment (73.%% on placebo and 73.2% on xaliproden) but it was significantly less likely that they would experience grade 3 neuropathy if they were taking xaliproden.  11.1% of those on xaliproden had sufficient neuropathy to interfere with their daily activities, compared to 16.7% of those taking a placebo — a 39% decrease.

Xaliproden had no effect on the acute neuropathy that is also a side effect of oxaliplatin — 80% of patients on both arms of the trial experienced extreme sensitivity to cold, about 17% had a painful feeling that they could not breathe, 10% had jaw pain, and 9% experienced muscle cramps.

There was no significant difference in treatment response rates (42.% on placebo, 44.9% on xaliproden), rates of stable disease (41.7% vs. 42.2% for xaliproden) or those patients whose cancers progressed during the trial (7.7% vs. 5.8%). Fewer patients discontinued treatment because of peripheral neuropathy, but 35% in both arms were were forced to stop chemotherapy because of some type of side effects, including peripheral neuropathy.

More people taking xaliproden had diarrhea, including severe diarrhea, dizziness, insomnia, swelling in their hands and feet and anxiety. There was also an increase in ear noises and vertigo, but they were not serious.

An article about the research is available on the February 24, 2006 Medical News Today web site. peripheral neuropathy xaliproden neurotoxicity

Posted by Kate Murphy on February 27th, 2006
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Molly McMaster swings a hockey stick at colon cancer

Molly McMaster, a colon cancer survivor, took to the ice in Glens Falls, NY on Sunday afternoon, February 26th, to skate with the UHL Adirondack Frostbite.  The Frostbite were battling the Richmond Riverdogs, and Molly was battling to raise awareness of colorectal cancer.

The Frostbite-Riverdogs hockey game was the first of 13 United Hockey League home games where Molly will skate at least one shift during the month of March — National Colorectal Cancer Awareness Month. McMaster, President of the Colon Club, has teamed up with the hockey league for UHL Cross-Checks Colon Cancer.

In addition to Molly’s appearance with the UHL teams, there will be educational information at games and the UHL players will all wear the colon cancer awareness Blue Star on their home jerseys.  Special announcements have been recorded by sports personalities Barry Melrose and Steve Levy to be run during game broadcasts.

Playing with the Adirondack Frostbite is defenseman Chris Mei, whose father died of colon cancer in 2003.  Remembering his dad, Mei says,

The Surgeon has told us that had my dad had a colonoscopy at the age of 50 as part of his regular physical exam, they would have noticed a polyp, removed it, and my dad may have still been here with us today.  What we wouldn’t give to rewind the time.  I can’t even begin to put into words how much he meant and continues to mean, to my family and all the people he came in contact with.  There is a huge hole in what our family used to be, and there isn’t a day that goes by that I don’t miss him. He wasn’t only my best friend but he is still my hero.

The complete schedule of UHL games featuring Molly McMaster is on the Colon Club web site.

Posted by Kate Murphy on February 26th, 2006
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MRI not helpful in finding local colorectal cancer recurrences when they are potentially curable

Could routine magnetic resonance imaging (MRI) help find recurrences of colorectal cancer that could be treated and cured surgically?

Knowing that surgical resection of recurrent colorectal cancer is the best option to cure the disease, surgeons added routine MRI surveillance to standard follow-up care for 226 patients with left-sided colon and rectal cancer.

Their results are reported in the March 2006 Annals of Surgery.

Pelvic recurrence was found in 30 (13%) of the 226 patients in the study.  MRI found nearly all of the recurrences — 26 of 30 or 87%.  Three of the 4 missed recurrences were at the place where the colon or rectum was surgically reconnected (anastomosis). In another 28 (14%) of patients, recurrence was suspected on the initial MR scan, but cleared after further testing.

The standard follow-up test CEA (carcinoembyonic antigen) was elevated for 19 of the 30 recurrences (63%), and 9 patients had cancer symptoms.

Potentially curative surgery was possible in only 6 patients (20%), and there was no difference between MRI and standard follow-up testing in identifying these patients.

The researchers concluded:

Pelvic surveillance by MRI is not justified as part of the routine follow-up after a curative resection for colorectal cancer and should be reserved for selectively imaging patients with clinical, colonoscopic, and/or biochemical suspicion of recurrent disease.

Posted by Kate Murphy on February 24th, 2006
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Fiber in the diet affects men and women differently

The affect of dietary fiber has been controversial in preventing colorectal cancer.  Observations of colorectal cancer rates in cultures where larger amount of fibrous food are eaten compared to Western diets led to theories that fiber might protect against the development of cancer.

However, no clear connection between the amount of fiber in the diet and the incidence of  polyps or cancer has been found in a number of studies.  In a new analysis combining  two previous studies that looked risk for colon polyps for men and women separately shows that fiber may help men, but not women.  The combined results were published in the February 2006 American Journal of Clinical Nutrition.

Researchers combined information from groups in both the Wheat Bran Fiber Study and the Polyp Prevention Trial.  Together there were about 3,200 participants who had pre-cancerous polyps (adenomas) removed during a baseline colonoscopy.  They were randomly assigned to either their usual diet or a high-fiber intervention diet with a follow-up colonoscopy 2–4 years later.

Although there was no significant difference overall between participants who had followed an enriched fiber diet and those who did not  the team did find that men had about a 20% reduction in recurrent polyps.  There was no similar difference for women.

The Wheat Bran Fiber Study design actually provided either a high-fiber or low-fiber cereal for participants. However, when results were published in the New England Journal of Medicine in April 2000, there were no significant differences between the two groups in those who had new polyps and those who didn’t.  The team did notice a difference for men, but given the number of male participants enrolled, this could have been due to chance.

In the Polyp Prevention Trial participants were randomly assigned to an intervention group that received nutrition counseling and were advised to eat a low-fat, high-fiber diet with with at least 3 1/2 servings of fruits and vegetables each day.  Both groups had about a 40% chance of having another polyp during the 4 year follow-up period, although most polyps were small.  About 5% in each group had an adenoma larger than 1 centimeter.  For whatever reason, there were more colorectal cancers found in the intervention group (10) than in the control group (4). The full report of the trial from the New England Journal of Medicine is online.

Read an article about the new analysis from Reuters.

Additional information about the Wheat Brain Fiber Study and the Polyp Prevention trial is available from the National Cancer Institute web site.

Posted by Kate Murphy on February 23rd, 2006
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