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Sponsored by: |
Pfizer |
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 |
Colorectal Neoplasms |
Drug: sunitinib + mFOLFOX6 Drug: bevacizumab + mFOLFOX6 |
Phase II |
MedlinePlus related topics: | Cancer Colorectal Cancer |
Drug Information available for: | Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Sunitinib Sunitinib malate Bevacizumab Fluorouracil Oxaliplatin |
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: | May 2013 |
Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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 |
Show 106 Study Locations |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
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Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181104 |
First Received: | January 25, 2008 |
Last Updated: | November 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00609622 |
Health Authority: | United States: Food and Drug Administration |
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