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Clinical Trials (PDQ®)

Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentCompleted18 and overPharmaceutical / IndustryA6181122
NCT00457691

Trial Description

Summary

The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding sunitinib as the first line treatment of patients with metastatic colorectal cancer.

Further Study Information

On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus FOLFIRI versus placebo plus FOLFIRI. No new safety findings were noted. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Patients receiving benefit on treatment as determined by the investigator may remain on study.

Eligibility Criteria

Inclusion Criteria:

  • Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
  • Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
  • Adequate organ function defined by blood test.

Exclusion Criteria:

  • History of another primary cancer in the last 3 years.
  • Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
  • History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.

Trial Contact Information

Trial Lead Organizations/Sponsors

Pfizer Incorporated

Pfizer CT.gov Call CenterStudy Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00457691
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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