Stage IV Colorectal CA ALIMTA
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|ClinicalTrials.gov Identifier: NCT00166465|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 14, 2011
Phase I: The primary objective of the Phase 1 portion of this study is to determine the Maximum tolerated dose and the recommended Phase 2 dose of ALIMTA plus oxaliplatin when given with folate and vitamin B-12 supplementation in the treatment of patients with unresectable, locally advanced or metastatic colorectal cancer. The Phase I component of the study will be activated for enrollment of Mayo Clinic patients only.
Phase II: The primary objective of the Phase 2 portion of this study is to determine the tumor response rates to ALIMTA plus oxaliplatin and oxaliplatin plus 5-fluorouracil and leucovorin in patients with locally advanced unresectable or Stage IV colorectal cancer that have not received prior chemotherapy for advanced disease. Patients will be randomly assigned to receive either ALIMTA plus oxaliplatin (Arm A) or Oxaliplatin plus 5-Fluorouracil and Leucovorin (Arm B). The Phase II component of the study will be activated for enrollment of patients via the Mayo Clinic Cancer Research Consortium mechanism. A comparison will be made of the side effects between regimens.
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Unresectable or Stage IV Colorectal Cancer||Drug: ALIMTA plus Oxaliplatin versus Oxaliplatin plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose-Finding Study and a Randomized Phase II Study of ALIMTA Plus Oxaliplatin Versus Oxaliplatin Plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen) in the First-Line Treatment of Patients With Locally Advanced Unresectable or Stage IV Colorectal Cancer|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||June 2006|
- Proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the exact binomial distribution.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166465
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Steven R. Alberts, M.D.||Mayo Clinic|