Docetaxel and Irinotecan in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00004923|
Recruitment Status : Completed
First Posted : April 28, 2004
Last Update Posted : August 25, 2009
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/II trial to study the effectiveness of docetaxel and irinotecan in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: docetaxel Drug: irinotecan hydrochloride||Phase 1 Phase 2|
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan when combined with docetaxel in patients with advanced solid malignancies. II. Determine the dose limiting toxicity of this regimen in these patients. III. Assess any antitumor activity of this regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study of irinotecan. Patients receive docetaxel IV over 1 hour followed immediately by irinotecan IV over 30 minutes on days 1, 8, 15, and 22. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, then every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 15-25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Official Title:||Dose Escalation Trial of Docetaxel Plus Irinotecan in Patients With Advanced Cancer|
|Study Start Date :||April 1999|
|Actual Study Completion Date :||May 2006|
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): NCT00004923
|United States, Connecticut|
|Yale Comprehensive Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|Bennett Cancer Center|
|Stamford, Connecticut, United States, 06902|
|Study Chair:||John R. Murren, MD||Yale University|