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3-AP Plus Cisplatin and Paclitaxel in Treating Patients With Advanced or Metastatic Cancer
This study is no longer recruiting patients.
Sponsored by: | Vion Pharmaceuticals |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
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 3-AP, cisplatin, and paclitaxel in treating patients who have advanced or metastatic cancer.
Condition | Treatment or Intervention | Phase |
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unspecified adult solid tumor, protocol specific |
Procedure: chemotherapy Drug: 3-AP Drug: cisplatin Drug: paclitaxel |
Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of 3-AP, Cisplatin, and Paclitaxel in Patients With Advanced or Metastatic Cancer
Study start: December 2000
OBJECTIVES: I. Determine the safety and tolerability of 3-AP, cisplatin, and paclitaxel in patients with advanced or metastatic cancer. II. Determine the toxic effects of this regimen in these patients. III. Determine the maximum tolerated dose and recommended phase II dose of this regimen in these patients. IV. Determine the pharmacokinetic parameters of this regimen in these patients. V. Determine the tumor response in patients treated with this regimen.
PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive 3-AP IV continuously over 96 hours on days 1-4 and paclitaxel IV over 3 hours followed by cisplatin IV over 1 hour on day 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 1 additional course of therapy after documented CR. Patients with partial response or stable disease may receive therapy for up to 6 months. Cohorts of 1-6 patients receive escalating doses of 3-AP, paclitaxel, and cisplatin 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.
PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Location Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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