Phase III trial underway to study Sutent for metastatic colorectal cancer

Posted by Kate Murphy on June 30th, 2007

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.

Technorati tags: Sutent, sunitinib, clinical trials

Comments (2): Add a comment

2 Responses to “Phase III trial underway to study Sutent for metastatic colorectal cancer”

February 12, 2009 at 1:55 am, Susan Harrold said:

Could you please tell me if this trial showed any positive results
February 12, 2009 at 8:37 am, Kate Murphy said:

The international Phase III trial of FOLFIRI and Sutent is still listed as “active”, which means that new patients are being enrolled in it.

It will be some time until all patients are enrolled, complete their treatment and followup, and results can be analyzed.

Until that time, it is not ethical for participants or their doctors to discuss partial results, even if they think they may know them. It is simply too early.

So there is no evidence — positive or negative — now.

A phase II study of 84 patients who got Sutent as a single agent and not in combination with other drugs did not find that it was effective.

Patients with colorectal cancer should only be using Sutent (sunitinib) as part of a clinical trial right now.

There are currently 7 active trials and 2 about to be activated exploring Sutent in colorectal cancer.

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