FDA approves generic ondansetron for nausea and vomiting caused by chemotherapy

The FDA approved the first generic version of injectable ondansetron on November 22, 2006.  Previously ondansetron was only available as the brand-name drug Zofran®.

Ondansetron is indicated to prevent nausea and vomiting during chemotherapy and to prevent nausea and vomiting after surgery

Approval is for injectable ondansetron manufactured by TEVA Pharmaceuticals and premixed ondansetron injections manufactured by SICOR Pharmaceuticals.

Gary J. Buehler, Director of the FDA Office of Generic Drugs, said,

These approvals will result in significant savings for the American public. Generic drugs undergo a thorough scientific and regulatory review, and are safe and effective alternatives to brand name drugs.

Posted by Kate Murphy on November 27th, 2006
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Clinical trial to test personalized approach to chemotherapy for metastatic colorectal cancer based on thymidylate synthase level

FEATURED CLINICAL TRIAL: ECOG-E4203

People with colon or rectal cancer that has spread (metastasized) may have different levels of a protein called thymidylate synthase (TS) in their tumors.  Previous studies have suggested that tumors with high levels of TS may be resistant to 5FU treatment.

Researchers want to know if replacing 5FU (fluorouracil) with irinotecan (Camptosar®) will improve the response to chemotherapy in patients with high TS levels.

A phase II clinical trial for first-line treatment of metastatic colorectal cancer ( ECOG-E4203 ) will test levels of thymidylate synthase in colon or rectal tumors and assign treatment strategies based on those results.

Patients with high levels of TS will randomly receive either:

• Arm 1:  An experimental treatment consisting of oxaliplatin (Eloxatin®) and irinotecan (Camptosar®) plus bevacizumab (Avastin®) at the beginning of each two week cycle. 
• Arm II: The current standard treatment of FOLFOX plus bevacizumab.  Bevacizumab and oxaliplatin are given intravenously on the first day followed by a two-day continuous infusion of 5FU.  The cycle is repeated every two weeks.

Patients with low TS levels will be given the same standard FOLFOX plus bevacizumab treatment  as in Arm II.

WHO IS ELIGIBLE FOR THE TRIAL?

• Patients with colon or rectal cancer that has spread (metastatic)
• No previous treatment for metastatic disease (first-line.)
• No serious heart or kidney disease, uncontrolled high blood pressure, or neuropathy.
• Tumor that can be measured.

WHERE IS THE TRIAL AVAILABLE?

The trial is being conducted by the Eastern Cooperative Oncology Group under the leadership of Neal Jay Meropol, M.D. and Jean Grem M.D. at community sites across the United States. 

A list of sites and contacts is available on Cancer.Gov or can be obtained by calling NCI’s Cancer Information Service at 1-800-4-CANCER. 

Additional help in enrolling or in finding a different clinical trial to meet your needs is available through the C3 Clinical Trials Matching Service at 1-866-278-0392.

ECOG-E4203 is one of the clinical trials eligible for special Medicare coverage under the  Medicare Anti-Cancer Drugs National Coverage Decision.   While Medicare covers the routine costs of cancer clinical trials, the nine trials that are part of the 2005 NCD have additional nonroutine expenses paid, as well as off-label uses of cancer drugs.

Posted by Kate Murphy on November 19th, 2006
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Kepivance (palifermin) reduces mouth sores from 5FU chemotherapy for colorectal cancer.

Palifermin (Kepivance®) reduced mouth inflammation and sores (mucositis) during treatment with 5FU and leucovorin for metastatic colon or rectal cancer.  The painful sores can make eating, drinking , and swallowing difficult and can lead to infection and the need to reduce chemotherapy.

Currently, the only proven effective prevention for chemotherapy-induced mucositis is cooling the mouth (cryotherapy) before and during treatment with 5FU.  Patients chew or suck on ice chips or popsicles.

Patients in the study were randomly assigned to either palifermin or a placebo intravenously for three days before each of two chemotherapy treatments .  Thirty-six patients received a placebo and 28 patients were given palifermin during the phase II clinical trial. 

Trial participants had metastatic colon or rectal cancer and were scheduled to receive bolus injections of 5FU (fluorouracil) and leucovorin for a five days in a row every four weeks. (Mayo Clinic Regimen)  Staff members examined their mouths and rated the extent of mucositis from grade 0 (none) to grade 4 where there were mouth sores so severe that eating was not possible at all.  Patients also completed a self-rating scale.

During the first chemotherapy cycle, patients receiving palifermin had half the incidence of grade 2 mucositis (appearance of mouth sores) as did those on placebo — 29% versus 61%.  During the second cycle fewer patients in both groups had grade 2 mucositis — 11% of those on palifermin and 29% of those receiving a placebo. 

However, patients with serious side effects during the first cycle of chemotherapy had their dose of 5FU reduced for the second one.  Fourteen percent of palifermin patients needed a reduced dose for the second cycle compared to 31% of patients on placebo.

Forty-six percent (46%) of patients who received palifermin had no mucositis at all compared to 17% of those on placebo.  No patients in either group experienced the most severe grade 4 mouth sores.

More patients on palifermin experienced an oral side effect (66%) than those on placebo (38%) including dry mouth, a white coating on the tongue, and taste changes. 

Palifermin had no effect on overall survival, time to disease progression, or progression-free survival which were similar for both treatment and placebo groups.  It also did not reduce the incidence of diarrhea.

Lee S. Rosen, M.D. and colleagues reported their results in the Journal of Clinical Oncology, November 20, 2006.  They wrote,

Palifermin is a novel therapeutic that may help reduce the incidence and duration of FU-induced mucositis, potentially allowing for uninterrupted full-dose treatment in patients receiving these chemotherapy
regimens. To date, only cryotherapy has been shown to have some benefit in reducing mucositis (although it has no effect for diarrhea) in patients undergoing FU chemotherapy.

 Palifermin is a laboratory-produced version of a natural protein that stimulates the growth of cells in the skin and the lining of the mouth and gastrointestinal tract called keratinocyte growth factor (KGF). Palifermin is marketed as Kepivance®  It is FDA approved for use in patients with blood cancers who are receiving high dose chemotherapy with stem cell support where severe mucositis is a serious side effect.

The study was supported by Amgen, Inc. who market Kepivance®.

Posted by Kate Murphy on November 18th, 2006
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C3’s Time for Reflection. C3’s Time for Action.

Editor’s note: Rob Michelson is a two-and-a-half-year survivor of stage IV rectal cancer. He has received radiation, numerous surgeries, and a variety of chemotherapies, and is still undergoing multi-modality treatment. Diagnosed at 37, Rob has managed to continue working nearly full-time, and be a husband and a father of three small boys, ages 7, 5, and 3.

Rob is an active participant in the Eastern Cooperative Oncology Group’s (ECOG) patient advocate committee, and has recently connected with C3.

As we come off the month of October, I have been reflecting on the colorectal cancer advocacy movement.

October is known in the cancer community and in the world as Breast Cancer Awareness month. As such, it is a difficult month for many of us in other cancer communities, such as colorectal cancer.

While we know that it took decades for October and breast cancer to become synonymous, it is nonetheless frustrating for those of us in the colorectal cancer advocacy community that March seems far away from gaining that level of recognition.

It is helpful at this time to reflect on some facts.

Fact: C3 is new.

It is incredible C3 has come this far in just 18 months in existence. C3 came out of a strong desire to do more than just “making people aware”, more than just “getting people to talk about CRC”, more than just “raising funds for awareness”, more than just “getting together”, more than just “supporting each other”…. C3 is about More. More Action, more Advocate Education, more Legislative Impact, more Funding, more Impact at FDA and NCI , more Research, and more Drugs in the Pipeline.

Fact: Building a base is important.

C3’s greatest asset is building the base, forming relationships in the cancer community, forming relationships with researchers, growing our network of advocates, training these advocates, and forming relationships with those on Capitol Hill.

Cancer does not discriminate by congressional district. Yet as the Hill has been transformed in recent days, we should reconnect with those in our base from districts whose representatives have new power.

These relationships provide immense value over time. These relationships allow us to build C3’s reputation. As C3 builds its reputation with our elected representatives, we gain legitimacy and trust, and empower ourselves to have an effective voice in Washington, and throughout our state capitols.

Relationships we build will lead to greater funding. Funding to colorectal cancer research will grow as we partner with advocates, such as Lisa Dubow, in establishing a dedicated fund to young investigators doing laboratory research focused on colorectal cancer. Since CRC does not discriminate, people in all walks of life – including government, business, entertainment – are affected. As our base grows, so does the potential for newer funding avenues, such as family endowment grants.

Relationships we build also give us a voice at the table with healthcare professionals. Through C3’s research advocacy efforts, CRC advocates are now seated at the table with Oncology Cooperative Groups, hospital Institutional Review Boards, and at conference dinners with researchers. When advocates are at these tables - we are active leaders, we speak with purpose, we speak from experience, and we have receptive audiences. We gain credibility, we learn, and “they” learn from our unique advocate perspective.

These relationships, without a doubt will result in a larger and diverse, yet more organized pool of grassroots advocates. Each of us brings unique talents to the cause, and as we grow our database and really understand each of our grassroots advocates, we will be better able to tap into each other’s unique talents and skills. Tapping into our database will enable us to speak with a more effective voice and make more effective decisions, and deliver a more focused message to those with whom we want to communicate.

I encourage everyone to keep expanding your own personal networks of contacts - and forward them to C3 when you make new ones.

Fact: Focus is important.

Caregivers of survivors and loved ones of those lost to the disease have so much energy, and they are looking both to C3 and within their hearts to determine the best way in which to contribute.

The fact that there is constant dialogue and there are questions on focus is a sign of our success and of our growth. In my own opinion, there is nothing more important than getting new drugs developed, tested, and available to those in life-threatening situations. Others have different areas of focus, and that’s why C3 exists. There are many of us, who decide to associate ourselves with other CRC organizations, too, and that in no way diminishes our commitment to C3.

C3 itself must remain focused. C3 must determine and revisit its mission and goals periodically. C3 must ensure, to the extent possible, that these goals are measurable and align with the mission, and that the actions align with C3’s goals. We must prioritize the tasks to ensure we remain effective and focused.

Fact: Awareness without Action has no Impact

Awareness requires an associated action to have impact. C3 staff have said this to me over and over again, and it took a long time to finally sink in. C3’s efforts are directed to action, thereby getting the most bang for the buck (the “buck” being our collective time and energy). The action can be “to get people screened” or “to meet with your member of Congress” or “to advocate at FDA”. Through action, CRC awareness becomes a free-by product. And that is where CRC efforts up to this point have diverged from AIDS advocacy and breast advocacy. In those successful movements, the advocacy largely preceded the awareness. Most CRC efforts still focus on awareness. C3 advocates through its action - and that’s what gives it its unique focus within the CRC community and gives it an opportunity to transform the movement for greater impact.

For example, this website is all about action. The more traffic we can generate to the website – the more likely people will be to become One-Minute Advocates, and the more likely people will support essential advocacy efforts and efforts to raise and direct research dollars, such as through the Lisa Fund, to researchers who dedicate themselves and their careers to treating and beating CRC through targeted research. As a result, our base grows, and new advocates are spawned to action.

In the end, such actions lead to awareness. The sea of blue stars, pins, and bracelets in March and year-round (with world-wide recognition) will follow soon enough as a natural byproduct of our work.

Posted by Rob Michelson on November 10th, 2006
Posted in: Policy & Advocacy News | No Comments »

Stage II and III colon cancer patients sought to review educational materials

People who had surgery for colon cancer following by chemotherapy (adjuvant chemotherapy) are being asked to review an audio CD produced by Research to Practice and participate in an interview afterwards.

Patients are eligible for the study if they

• Were diagnosed with stage II or III colorectal cancer within the past five years.
• Had surgery and adjuvant chemotherapy following it

People who are eligible for the current study will be asked to

1. Listen to parts of an audio CD at home and complete a survey while listening.
2. Participate in a 30 to 40 minute telephone interview about their experiences with oncology professionals, their therapies, how they received colorectal cancer information, and how they perceived benefits of treatment and side effects.
3. In addition, evaluate the Research to Practice patient website for those with Internet access..

There is a $125 honorium for completing Parts 1 and 2 of the project with an additional $50 for those who also evaluate the website.

If you would like to participate, telephone 1-800-535-0109.

A previous report of Patient Perspectives on Colorectal Cancer is available online.

Posted by Kate Murphy on November 6th, 2006
Posted in: Research & Treatment News | No Comments »