Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00003255|
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : July 12, 2016
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 II trial to study the effectiveness of combining carboplatin and topotecan in treating patients with relapsed acute myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: carboplatin Drug: topotecan hydrochloride||Phase 2|
OBJECTIVES: I. Determine the efficacy of a 5-day continuous infusion of carboplatin and topotecan in patients with relapsed and refractory acute myelogenous leukemia (AML). II. Assess the toxic effects of this treatment in these patients.
OUTLINE: Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Experimental: topotecan + carboplatin
Patients receive continuous intravenous infusions of topotecan and carboplatin for 5 days. Treatment repeats every 3-4 weeks during induction (two courses) and every 6-10 weeks during consolidation. No more than four courses of treatment are given. Patients are followed every 6 months for 5 years.
Drug: topotecan hydrochloride
- overall survival [ Time Frame: Up to 5 years ]
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): NCT00003255
|Study Chair:||Scott H. Kaufmann, MD, PhD||Mayo Clinic|