Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
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|ClinicalTrials.gov Identifier: NCT00004173|
Recruitment Status : Unknown
Verified July 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : May 15, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of oxaliplatin and paclitaxel in treating patients who have metastatic or unresectable cancer.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: oxaliplatin Drug: paclitaxel||Phase 1|
- Determine the maximum tolerated dose of oxaliplatin and paclitaxel in patients with metastatic or unresectable cancer.
- Determine the qualitative and quantitative toxicities of this regimen in these patients.
- Determine the therapeutic response to this regimen in these patients.
- Determine the relationship between the pharmacokinetics of this regimen and toxicity and response in these patients.
- Determine the effects of oxaliplatin on peripheral blood cells and correlate this to pharmacokinetics, toxicity, and response in these patients.
OUTLINE: This is a dose escalation study.
Patients receive oxaliplatin IV over 2 hours followed by paclitaxel IV over 1 hour weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase I Study of Oxaliplatin in Combination With Paclitaxel|
|Study Start Date :||October 1999|
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): NCT00004173
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Eric H. Kraut, MD||Ohio State University Comprehensive Cancer Center|