A clinical trial to study the effect of chemotherapy (FOLFIRI) with or without Sunitinib Malate in patients with metastatic cancer of colon/rectum.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Metastatic Colorectal Cancer
- Registration Number
- CTRI/2011/091/000025
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 720
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Progression-free survivalTimepoint: [ Time Frame: 18 months ]
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures: <br>â?¢Overall survival [ Time Frame: 24 months ]<br>â?¢Objective Response rate [ Time Frame: 18 months ]<br>â?¢Duration of Response [ Time Frame: 18 months ]<br>â?¢Adverse Events [ Time Frame: 18 months ]<br>â?¢Patient Reported Outcomes [ Time Frame: 18 months ]Timepoint: