Medicare coverage of off-label drugs in clinical trials: four trials now open

In January 2005, the Centers for Medicare and Medicaid Services made a National Coverage Decision (NCD) that they would cover off-label use of certain drugs if they were part of 9 specific NCI-sponsored clinical trials.  Trials include treatment for colorectal cancer, pancreatic cancer, cancer of the larynx, and gastrointestinal stromal tumors.The NCD covered drugs are:

• oxaliplatin (Eloxatin™
• irinotecan (Camptosar™)
• bevacizumab (Avastin™)
• cetuximab (Erbitux™)

Four of the nine trials are now open and recruiting patients according to the National Cancer Institute — four trials for colorectal cancer and one for patients with cancer of the larynx.  Plans for the other five trials — one for metastatic colorectal cancer, two for rectal cancer, one for pancreatic cancer, and another for gastrointestinal stromal tumor are currently in the process of being reviewed for approval by the NCI.

Trials recruiting patients now include

• A nationwide randomized phase III trial for patients who have not yet received chemotherapy for metastatic colorectal cancer comparing FOLFIRI or FOLFOX combined with (1) bevacizumab (2) cetuximab or (3) both bevacizumab and cetuximab.  NCI information for C80405.
• A phase II trial for patients newly diagnosed with metastatic colorectal cancer.  Chemotherapy regimens will be based on levels of the enzyme thymidylate synthase (TS) expressed by the individual patient’s tumor.  Patients with high levels of TS will randomly receive either (1) bevacizumab, oxaliplatin, and irinotecan or (2) bevacizumab and FOLFOX.  Those with low levels of TS will receive bevacizumab and FOLFOX.  NCI information for E4203.
• A randomized phase II trial for patients with high risk stage II colon cancer after surgery to remove the colon tumor (adjuvant therapy).  Patients will be randomized to receive either (1) FOLFOX or (2) FOLFOX with bevacizumab. NCI information for E5202.
• A randomized phase III trial that compares radiation therapy for cancer of the larynx without and without cetuximab.  NCI information for RTOG-0522.

The National Cancer Institute’s cancer.gov clinical trials listings provide detailed information about the study protocols, who is eligible for each study, where the study is being conducted, and who to contact for enrollment.

Centers for Medicare and Medicaid Services will continue to cover the four drugs for treatment that includes:

• Uses that are part of the FDA approved label.
• Uses supported by one of the recognized reference lists of drugs (compendia)
• Off-label use that has been determined by a local Medicare contractor to be medically acceptable.

Since 2000, Medicare has covered the routine patient care costs during clinical trials.  In addition, some insurance plans pay for such care.  A number of states now require insurance to cover routine care costs during cancer clinical trials.  Routine care includes usual medical care such as doctor visits, hospital stays, tests and similar services that patients would receive even if they were not in a clinical trial.  Special research requirements such as data collection or unusual testing necessary for the clinical trial only are usually not covered by either Medicare or insurance but are frequently paid for by the clinical trial program itself.  NCI has additional information about Medicare and cancer clinical trials.

Posted by Kate Murphy on January 16th, 2006
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Clinical Trial Open: Vaccine therapy after resection of liver mets

 Vaccine Therapy in Treating Patients With Liver Metastases From Colorectal Cancer

A clinical trial for people with colorectal cancer who have had surgery to remove liver metastases is actively enrolling patients at Duke Comprehensive Cancer Center in Durham, North Carolina.  After surgery, patients in the study will be randomized to receive vaccine therapy in one of two ways.

• Arm 1:  Patients will have some white blood cells removed from their blood and the dendritic cells treated in the lab with the two vaccines being used for the trial (PANVAC-V and PANVAC-F). On the first day of trial treatment, patients will receive their own dendritic cells, which have been treated with PANVAC-V, by an injection under the skin (autologous DC).  On the second day, autologous dendritic cells treated with PANVAC-F will be injected.  The second-day treatment will be repeated 1, 7, and 11 weeks later.
• Arm 2:  Patients will not have dendritic cells removed and treated for autologous injection.  Instead they will receive PANVAC-V on the first day of treatment and PANVAC-F at the beginning of the 4th, 8th, and 12 weeks. They will also receive  receive sargramostim (GM-CSF) for three days at the time of each vaccine treatment. 

The goal of the phase II clinical trial is to compare disease-free survival for two years after liver resection using two different approaches to vaccine therapy.

To be eligible for the trial a patient must:

• Have confirmed liver metastases from colorectal cancer.
• Have had surgery to remove those liver mets completely — no evidence of remaining cancer.
• Have completed up to 6 months of chemotherapy within the previous 1 to 3 months.
• Not have had their spleen removed.

The National Cancer Institute clinical trials database health professional version has more specific requirements for trial participation.

Patients may also want to see the NCI patient version of the trial.

PANVAC-V is vaccinia-CEA-MUC-1-TRICOM vaccine.  PANVAC-F is fowlpox-CEA-MUC-1-TRICOM vaccine  Both are used in both arms of the trial.

For more information or to enroll contact:

• Michael Moore, MD
•  919–681–3480
• Duke Comprehensive Cancer Center

You may also want to use the C3 Clinical Trials Matching Service at 1–866–278–0392.

Protocol ID: 
DUMC-5883-04-6RO
NCT00103142

Protocol Title:  Phase II Randomized Study of Adjuvant Vaccine Therapy Comprising Vaccinia-CEA-MUC-1-TRICOM Vaccine (PANVAC-V) and Fowlpox-CEA-MUC-1-TRICOM Vaccine (PANVAC-F) Administered With Autologous Dendritic Cells or Sargramostim (GM-CSF) in Patients With Completely Resected Hepatic Metastases Secondary to Colorectal Cancer

Posted by Kate Murphy on January 9th, 2006
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Elizabeth Parcells 1951-2005

Our dear friend Elizabeth Parcells died on December 29, 2005 at home with her family, in the way she had so very much wished.  Elizabeth’s courage and sheer joy has encouraged all of us on the ACOR Colon Discussion List as she moved with grace and dignity through the last months of her life.  She kept her sense of humor, her optimism, and her willingness to share both difficult times and better days.

A concert soprano, she made her last work putting her music up on a web site where it could be freely enjoyed by everyone and where she could continue her work to make people aware that colorectal cancer was preventable through screening.

In February, 2005 she returned to the concert stage at Carnegie Hall after two years of struggling with colorectal cancer.  She had decided to make that performance an opportunity to spread the word about colorectal cancer.  She had ordered enough blue buddy bracelets for the entire audience.  Afterwards she wrote:

Before I began to sing, I made a few remarks.  I thanked Pro Musicis Foundation for their faith in me over the years, and especially when they invited me to sing in spite of my cancer situation.  Then I spoke directly to my audience and told them that I had a very personal message and a gift for each one of them.  I asked them to be aware that colon cancer can be treated early and even prevented by a colonoscopy, that there was a buddy bracelet for each of them to remind them or a loved one of this, to get the bracelet, to wear it for me, and get the test for themselves.  I added that if my initiative saved but one life, it would all be worth it.

When I came back on stage after the intermission, it was a joy to see a blue bracelet on every wrist in the hall!

Of all the triumphs I could wish for as a singer and a human being, this was the greatest moment of all.

 Her family has added a memorial page to her website where stories and memories of Elizabeth can be shared.  Send messages to Charlie Parcells, and he will post them there.

The funeral will be held on January 4, 2005 at the Jefferson Avenue Presbyterian Church in Detroit, Michigan.  Calling hours are from 2 to 9 p.m. on January 3rd at the Verheyden Funeral Home, 8325 East Jefferson Avenue, Detroit.

An obituary for Elizabeth — or Betsy as she was known in the musical world — appeared in the January 8th edition of the *Boston Globe.*

Posted by Kate Murphy on January 1st, 2006
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My New Year Wishes

New Year’s Day is a time of introspection for me —. a day that is usually quiet and often, in this cloudy upstate New York landscape, snowy and a bit bleak.  I keep my Christmas decorations up in January to provide light and some glitter against the cold and give me time to daydream. 

It’s been twelve years since I spent New Year’s Day waiting for surgery to remove a mass on my ovary.  It had been about 18 months since my second colon cancer had been discovered, and this new mass was (1) no cancer at all (very unlikely)  (2) a brand-new ovarian primary cancer (not good news, but better than the alternative) which was (3) a metastasis of the colon cancer.  Dumb luck, many prayers, a tickled DNA?  Who knows, but in January 2006 I have been cancer-free for 12 years after surgery and chemotherapy that essentially cured ovarian cancer.

Of course, the second-shoe of hereditary non-polyposis colon cancer (HNPCC or Lynch Syndrome) hangs over my head, waiting to bring fresh excitement into an already too-full-of-excitement life.  I’ll have an annual colonoscopy in a couple of weeks to keep an eye on any polyps that might be waiting in the wings, but obsessing about dangling shoes or unlucky swords of Damocles isn’t much my style anymore. I plan to keep on keeping on in 2006, staying as healthy and busy as I possibly can.

Here’s my 2006 New Year’s Wish List:

• A simple, non-invasive screening test for colorectal cancer that is as sensitive as colonoscopy in finding polyps before they become cancer
• While we are waiting for that test, a way of preparing for colonoscopy that is safe, tasty, and doesn’t provoke nausea, vomiting, or cramps.
• A reliable way to predict which patients will benefit from chemotherapy and which ones really don’t need the risks and hassles.
• Methods to reduce oxaliplatin neuropathy and the skin rash from Erbitux and panitumumab.
• No more diarrhea!
• Treatment for metastatic colorectal cancer that CURES . . .  or at least keeps the cancer in check without suffering until people with the disease can die of a quiet and peaceful old age.
• One hundred percent public awareness that colorectal cancer can be prevented through timely and effective screening.
• A health care system that pays for quality screening and state-of-the-art treatment for everyone — rich or poor.
• Solid clinical trials that fill up fast, zip to conclusions, and are the offered to every newly diagnosed patient as a first treatment choice.

Cock-eyed optimist that I am, I fully believe that these are reasonable, do-able wishes.  They will take dedication, but there is lots of that available from researchers, advocates, and planners.  They will take money, of course, but lack of funding should never get in the way of dreams.

So, let’s dream that 2006 brings us giant steps toward ending death and suffering from colorectal cancer — and that patients, caregivers, and survivors find health, strength, and peace in their struggles.

Posted by Kate Murphy on January 1st, 2006
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Obesity and lack of physical exercise increase risk of colorectal cancer death

Colorectal cancer patients who had little physical activity and excess abdominal fat  prior to their diagnosis were more likely to die of the disease.  A study of patients in Australia found that body fat, waist circumference, and exercise patterns were all related to risk of death from colorectal cancer.

Researchers reviewed information from nearly 42,000 people enrolled in the Melbourne Collaborative Cohort Study from 1990 through 1994.  When individuals entered the study, their body measurements and exercise activity were recorded.

Between 1994 and 2002, there were 526 cases of colorectal cancer in the cohort, including 181 deaths from the disease.  Analyzing the deaths 5 1/2 years after diagnosis and the information about body fat and exercise obtained at the beginning of the study, the research team found:

• Non-exercisers were 27% more likely to die of colorectal cancer.
• The greatest exercise impact was for stage II and III cancers, where exercise reduced the risk of death in half.
• Obesity increased the risk of death by 1/3, particularly when fat was located around the waist.

Dr. A.M.M. Hayden and colleagues at the Monash Medical School in Melbourne, Australia reported the results of their study in the January, 2006 issue of GUT. They concluded:

Increased central adiposity and a lack of regular physical activity prior to the diagnosis of colorectal cancer is associated with poorer overall and disease specific survival.

Posted by Kate Murphy on December 31st, 2005
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