|Phase III||Treatment||Completed||18 and over||Pharmaceutical / Industry||A6181122|
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.
- 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.
- 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 Lead Organizations/Sponsors
|Pfizer CT.gov Call Center||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00457691
ClinicalTrials.gov processed this data on October 17, 2013
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