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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00609622 |
This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.
Condition | Intervention | Phase |
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Colorectal Neoplasms |
Drug: sunitinib + mFOLFOX6 Drug: bevacizumab + mFOLFOX6 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Phase 2B Study Of Sunitinib Plus Oxaliplatin, 5-Fluorouracil And Leucovorin (FOLFOX) Versus Bevacizumab Plus FOLFOX As First-Line Treatment In Patients With Metastatic Colorectal Cancer |
Estimated Enrollment: | 290 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Treatment arm A - sunitinib plus mFOLFOX6
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Drug: sunitinib + mFOLFOX6
Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2). FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of:
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B: Active Comparator
Treatment arm B - bevacizumab plus mFOLFOX6
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Drug: bevacizumab + mFOLFOX6
Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks. FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of:
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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:
Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181104 |
Study First Received: | January 25, 2008 |
Last Updated: | January 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00609622 |
Health Authority: | United States: Food and Drug Administration |
metastatic colorectal cancer,
sunitinib (Sutent),
bevacizumab (Avastin),
randomized study |
Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Leucovorin Bevacizumab Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Oxaliplatin Digestive System Diseases Sunitinib Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |