Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00003742|
Recruitment Status : Completed
First Posted : March 15, 2004
Last Update Posted : June 21, 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 combination chemotherapy in treating patients with locally advanced or metastatic solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: cisplatin Drug: irinotecan hydrochloride Drug: paclitaxel||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of paclitaxel when combined with cisplatin and irinotecan in patients with locally advanced or metastatic solid tumors. II. Determine the dose limiting toxicity of paclitaxel when combined with cisplatin and irinotecan in this patient population. III. Establish the recommended phase II dose for this regimen in this patient population. IV. Assess the antitumor activity of this regimen in selected solid tumor malignancies.
OUTLINE: This is a dose escalation study of paclitaxel. All patients receive paclitaxel IV over 1 hour, then cisplatin IV over 30 minutes, followed by irinotecan IV over 30 minutes weekly for 4 weeks on days 1, 8, 15, and 22. Treatment is repeated every six weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel. If 2 or more patients experience dose limiting toxicity (DLT) at a particular dose level, escalation ceases and the maximum tolerated dose (MTD) is defined as the previous dose level. Patients are followed until death.
PROJECTED ACCRUAL: Approximately 12-27 patients will be accrued for this study within 6-9 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I Trial of Paclitaxel, Cisplatin, and Irinotecan in Patients With Advanced Solid Tumor Malignancies|
|Study Start Date :||October 1998|
|Actual Primary Completion Date :||August 2001|
|Actual Study Completion Date :||August 2001|
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): NCT00003742
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David H. Ilson, MD, PhD||Memorial Sloan Kettering Cancer Center|