A Phase 4 interventional study of oxaliplatin in Colorectal Cancer, sponsored by Sanofi. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-13.
Sponsored by Sanofi · Phase 4, Interventional, and Treatment
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:
The secondary objectives are:
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's enrollment of 180 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.
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The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.
Inclusion Criteria:
Exclusion Criteria:
Time to treatment failure (TTF) for the conventional oxaliplatin (CO) schedule in comparison with the intermittent oxaliplatin (IO) schedule
The incidence of adverse events, including neurotoxicity, as determined using the National Cancer Institute (NCI) Common Toxicity Criteria version 3.0 (CTCAE v3.0)
Quality of life, including oxaliplatin-specific neurologic symptoms determined using the PNQoxali
Tumor response rate (overall and confirmed) based on application of the Response Evaluation Criteria in Solid Tumors (RECIST)
Time to tumor progression (TTP)
Time of tumor control (TTC)
Overall survival (OS)
Reasons for treatment discontinuation
This study is terminated, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxaliplatin