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NCT00129870 · ClinicalTrials.gov registry record · Phase 4
CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer
A Phase 4 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
NCT00129870 is a Phase 4 study that was terminated before completion, run by Sanofi. The registered enrollment target is 180 participants.
The verdict
NCT00129870, a Phase 4 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
Study Summary
The primary rationale for this study is to develop an optimized schedule of administration of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. The hypothesis is that the use of an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow these patients to continue on treatment for a longer period of time by reducing the proportion of patients who discontinue therapy early because of treatment-related toxicities and thus increasing the possibility of a longer time to progression. The primary objective is: * To test the hypothesis that an intermittent oxaliplatin (IO) schedule of FOLFOX/bevacizumab will allow patients to remain on therapy for a longer period of time compared to a conventional "treat-to-failure" schedule, by reducing the proportion of patients who discontinue therapy for treatment-related toxicities. The secondary objectives are: * To evaluate the impact of calcium/magnesium infusions on the incidence and severity of neurotoxicity in subjects receiving either the IO or conventional FOLFOX/bevacizumab treatment schedules as first-line treatment for metastatic colorectal cancer. * To evaluate the safety and efficacy of the IO versus the conventional schedule + calcium and magnesium infusions, as part of oxaliplatin-based first-line therapy for metastatic colorectal cancer.
Interventions
- DRUG oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2005-02 |
| Est. Completion | 2007-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00129870
The ClinicalTrials.gov registry entry for NCT00129870 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which oxaliplatin is the first listed.
NCT00129870 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00129870 about?
NCT00129870 is a clinical study titled "CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer". The primary rationale for this study is to develop an optimized schedule of administration of FOLFOX + bevacizumab that maximizes the efficacy and safety of this regimen when administered to patients with advanced colorectal cancer. The hypothesis is that the use of an intermittent oxaliplatin (IO) ...
What is the current status of trial NCT00129870?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2005-02. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00129870?
The interventions under investigation include: oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00129870?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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