Phase III trial underway to study Sutent for metastatic colorectal cancer

Pfizer has announced the opening of a multinational Phase III clinical trial to study the safety and effectiveness Sutent (sunitinib malate) combined with FOLFIRI chemotherapy as first-line treatment for colorectal cancer that has spread to organs beyond the colon or rectum.  The trial is designed to be first-line treatment for metastatic cancer.

Seven hundred patients will be recruited internationally and randomized to receive either:

• FOLFIRI — Irinotecan, leucovorin, and continuous infusion 5FU – plus a placebo
• FOLFIRI plus sunitinib

The clinical trial is open and recruiting patients in Europe, Canada, Asia, and South America.

Who is eligible?

• Patients with confirmed colorectal cancer that has spread to organs beyond the colon (metastatic disease).
• Patients who have received no other treatment for metastatic colorectal cancer.
• Patients for whom treatment with FOLFIRI is indicated.
• Patients whose overall organ functioning is adequate based on blood tests.

Who is not eligible?

• Patients who have had different primary cancer within the past three years.
• Patients who have had full field radiotherapy within 4 weeks of enrollment, who have received partial field radiotherapy within 2 weeks, or who have had radiation treatment to more than 30% of their bone marrow.
• Patients whose cancer has spread to their brain or who have compression of their spinal cord.

For more information about the trial, call 1-877-369-9753.

Posted by Kate Murphy on June 30th, 2007
Posted in: Research & Treatment News | No Comments »

Phase I data shows safety and activity for FOLFIRI plus Sutent in patients with metastatic colorectal cancer

NEWS FROM 2007 WORLD CONGRESS ON GASTROINTESTINAL CANCER

Sutent® (sunitinib maleate) combined with FOLFIRI chemotherapy was active and generally well-tolerated in previously untreated patients with colorectal cancer that had spread according to a Phase I study presented at the World Congress on Gastrointestinal Cancer in Barcelona.

Ten patients received Sutent daily for four weeks, followed by two weeks of rest.  They were also getting FOLFIRI chemo treatments.  FOLFIRI is a combination of intravenous irinotecan, leuvocorin, and 5FU.  The 5FU is given as continuous infusion.

Of the 10 patients in the trial, 4 had a partial response and 6 have had stable disease.  Serious side effects included one respiratory infection and two cases of low white cell counts (neutropenia) with fever.

Alfredo Carrato, MD, who will lead a multinational randomized Phase III study of FOLFIRI plus Sutent, said,

Despite progress in recent years, colorectal cancer remains a hard-to-treat cancer for which new options are sorely needed. These data support further research of sunitinib malate in metastatic colorectal cancer, in an effort to potentially expand the range of therapies available to physicians and patients.

Sutent is currently indicated for patients with advanced renal cell carcinoma or gastrointestinal stromal tumor (GIST).

WHAT THIS MEANS FOR PATIENTS

These are results of a small Phase I study whose goal was to find a dose of Sutent that is safe and has tolerable side effects.  Effectiveness is not an objective of Phase I clinical trials.

The trial was designed for patients who had not been previously treated for metastatic colorectal cancer, so it is not reasonable to conclude that it might have similar activity in patients who had already had other treatments.

It is too soon to assume that Sutent and FOLFIRI  might be a better treatment than FOLFIRI alone.  A randomized Phase III trial is planned to answer that question.

Posted by Kate Murphy on June 30th, 2007
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Probiotic drinks help prevent diarrhea during antibiotic treatment

A commercially available yogurt drink can reduce diarrhea and infection associated with use of antibiotics according to a study in the British Medical Journal.  

Older adults who used a probiotic yogurt drink while they were taking antibiotics had 75 percent less diarrhea and no diarrhea associated with c. difficile infection than a similar group who drank a milkshake without active microorganisms.  The two groups were randomized and double-blinded.  Neither participants or nursing staff knew who was receiving what drink.

None of the patients in the study had diarrhea or bowel disease before beginning the study or were lactose intolerant.

Patients in three London hospitals began drinking Actimel® within 48 hours of starting antibiotic therapy and continued using it twice a day until a week after the antibiotics ended.  A control group drank Yazoo®, a sterilized milkshake also commercially available in the United Kingdom. 

During the study

• 12 percent of patients on Actimel developed diarrhea compared to 34 percent of those in the control group.
• No c. difficile was found in the stool of any of the Actimel group compared to 17 percent of controls who developed diarrhea associated with c. difficile infection.

Research dietician Mary Hickson and her team wrote,

Consumption of a probiotic drink containing L casei, L bulgaricus, and S thermophilus can reduce the incidence of antibiotic associated diarrhoea and C difficile associated diarrhoea. This has the potential to decrease morbidity, healthcare costs, and mortality if used routinely in patients aged over 50.

According to the World Health Organization, probiotics are living microorganisms that, when administered in adequate amounts, confer a health benefit on the host .  They contribute to maintaining a healthy balance of beneficial and harmful bacteria in the intestinal tract.

Actimel contains Lactobacillus casei, L casei imunitass, S thermophilus and L bulgaricus.  The research team tested the drinks to be sure that the bacteria were live and active.  It is marketed in the United States as DanActive®.

WHAT THIS MEANS FOR PATIENTS

Although there was a large reduction in diarrhea associated with antibiotic use and no c. difficile infection at all in those patients who drank Activel during their antibiotic therapy, this preventive may not be appropriate for everyone.

• People with diarrhea or bowel disease were excluded from the study.
• The authors point out that they were unable to pinpoint which of the live microorganisms was responsible for the protection from diarrhea and infection so the information may not be valid for other yogurt or probiotic products.
• The drink prevented diarrhea.  It was not used to treat it.

 SOURCE:  Hickson et. al. British Medical Journal, June 29,2007.

Posted by Kate Murphy on June 30th, 2007
Posted in: Research & Treatment News | 2 Comments »

Do you have questions about adjuvant treatment for colon or rectal cancer?

Listen to interviews with oncologists and patients at Cancer Questions and Answers to get some real-world perspective on issues such as:

• What is adjuvant therapy and why might I need it?
• What are the common side effects of the most common chemotherapy?
• What will life be like when adjuvant therapy is over?

The interviews can be read or listened to online, and can be downloaded to MP3 players.

Participating oncologists include:

• George Fisher MD PhD, Stanford University
• Axel Grothey* MD, Mayo Clinic
• John Marshall* MD, Lombard Cancer Center
• Neal Meropol* MD, Fox Chase Cancer Center
• Leonard Saltz MD, Memorial Sloan Kettering Cancer Center
• Robert Wolff MD, MD Anderson Cancer Center

* Member of C3 Medical Review Network

This website was developed by Research to Practice, a medical education company headed by Dr. Neil Love.

Posted by Judi Sohn on June 27th, 2007
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Adding calcium/magnesium to FOLFOX+Avastin may reduce its effectiveness

By Andy Giusti, Ph. D, C3 Research Program Manager

A phase IV clinical trial designed to test if calcium/magnesium infusions lessened neuropathy when administered with Eloxatin (oxaliplatin) as part of the common FOLFOX+Avastin chemotherapeutic regimen has been closed. The manufacturer of Eloxatin, Sanofi-Aventis has stopped the trial after an interim analysis indicated that the use of calcium/magnesium could reduce the effectiveness of this chemotherapy treatment.

Read the text of the alert here in PDF format.

This study compared the use of calcium/magnesium infusions vs. placebo in previously untreated colorectal cancer patients receiving FOLFOX+ Avastin. The objective of the study was to determine if the addition of calcium/magnesium would reduce the severity or incidence of neuropathy, a commonly observed side effect in patients that are receiving Eloxatin as part of their chemotherapy treatments.

The trial was stopped while Sanofi-Aventis performs a more complete analysis of their data. It should be noted that this was not a safety issue with Eloxatin, but rather an issue of reduced efficacy when using calcium/magnesium in an attempt to lessen the side effects of Eloxatin treatment.

Until this analysis is made available, patients should carefully weigh the supposed benefit of decreased neuropathy that may be obtained when using calcium/magnesium, with the potentially more serious prospect of reduced effectiveness of their chemotherapy treatment.

Disclosure: C3 has accepted funding for projects and educational programs from Sanofi-Aventis in the form of charitable donations. C3 has ultimate authority over website content.

Posted by Andy Giusti on June 26th, 2007
Posted in: Research & Treatment News | 2 Comments »