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NCT00166465 · ClinicalTrials.gov registry record · Phase 1
Stage IV Colorectal CA ALIMTA
A Phase 1 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 200
- Enrollment target
NCT00166465: Completed Phase 1 study, sponsored by Mayo Clinic.
NCT00166465 is a Phase 1 study that has completed, run by Mayo Clinic. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00166465, a Phase 1 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 200 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG ALIMTA plus Oxaliplatin versus Oxaliplatin plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2003-08 |
| Est. Completion | 2006-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00166465
The ClinicalTrials.gov registry entry for NCT00166465 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ALIMTA plus Oxaliplatin versus Oxaliplatin plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen) is the first listed.
NCT00166465 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00166465 about?
NCT00166465 is a clinical study titled "Stage IV Colorectal CA ALIMTA". 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 metas...
What is the current status of trial NCT00166465?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2003-08. Estimated completion is 2006-06.
What interventions are being tested in trial NCT00166465?
The interventions under investigation include: ALIMTA plus Oxaliplatin versus Oxaliplatin plus 5-Fluorouracil and Leucovorin (FOLFOX 4 Regimen) (DRUG).
Who is sponsoring clinical trial NCT00166465?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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