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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00457691 |
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.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: 5 fluorouracil Drug: irinotecan Drug: levo- leucovorin Drug: sunitinib Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomised, Double-Blind, Phase 3 Study Of Sunitinib In Metastatic Colorectal Cancer Patients Receiving Irinotecan, 5-Fluorouracil And Leucovorin (FOLFIRI) As First Line Treatment. |
Estimated Enrollment: | 720 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
Drug: irinotecan
180mg/m2 iv day 1 every 14 days
Drug: levo- leucovorin
200mg/m2 iv; day 1 every 14 days
Drug: sunitinib
37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
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2: Placebo Comparator |
Drug: 5 fluorouracil
400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
Drug: irinotecan
180mg/m2 iv day 1 every 14 days
Drug: levo- leucovorin
200mg/m2 iv; day 1 every 14 days
Drug: placebo
37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181122 |
Study First Received: | April 4, 2007 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00457691 |
Health Authority: | United States: Food and Drug Administration |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Irinotecan Leucovorin Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Digestive System Diseases Sunitinib Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Vitamin B Complex Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Vitamins Growth Inhibitors Angiogenesis Modulating Agents Micronutrients Antineoplastic Agents, Phytogenic |