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CONCEPT: Comparison of Oxaliplatin vs Conventional Methods With Calcium/Magnesium in First-Line Metastatic Colorectal Cancer

NCT00129870 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2009-02-13

No results posted yet for this 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.

Conditions

Interventions

DRUG

oxaliplatin

Sponsors & Collaborators

Principal Investigators

  • Yasir Nagarwala, M.D. · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Completion
2007-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00129870 on ClinicalTrials.gov