Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00005078|
Recruitment Status : Completed
First Posted : May 16, 2003
Last Update Posted : June 8, 2015
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 combining tirapazamine, carboplatin, and paclitaxel in treating patients who have advanced malignant solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: carboplatin Drug: paclitaxel Drug: tirapazamine||Phase 1|
- Determine the maximum tolerated dose of tirapazamine in combination with carboplatin and paclitaxel in patients with advanced solid tumors who have or have not received prior chemotherapy.
- Assess the toxicity and preliminary efficacy of this regimen in these patients.
- Determine the pharmacokinetic profile of this regimen in these patients.
- Investigate potential predictors of response by studying patient tissue specimens after receiving this regimen.
OUTLINE: This is a dose-escalation study of tirapazamine. Patients are stratified according to prior chemotherapy status (previously untreated vs previously treated).
Patients receive tirapazamine IV over 2 hours, paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes. Treatment continues every 21 days for a maximum of 8 courses in the absence of unacceptable toxicity or disease progression. Some patients may continue therapy in the absence of unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of tirapazamine 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. An additional 12 patients in the previously untreated stratum are treated at the MTD.
Patients are followed indefinitely.
PROJECTED ACCRUAL: A total of 36-68 patients (18-34 per stratum) will be accrued for this study within 12-18 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Official Title:||Phase I Dose Escalation Study of Tirapazamine (NSC 130181) in Combination With Carboplatin and Paclitaxel in Advanced Malignant Solid Tumors|
|Study Start Date :||March 2000|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
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): NCT00005078
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010-3000|
|USC/Norris Comprehensive Cancer Center and Hospital|
|Los Angeles, California, United States, 90033-0804|
|City of Hope Medical Group|
|Pasadena, California, United States, 91105|
|University of California Davis Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Stephen Shibata, MD||City of Hope Medical Center|