Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed/Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome
|ClinicalTrials.gov Identifier: NCT00005593|
Recruitment Status : Completed
First Posted : February 25, 2004
Last Update Posted : June 11, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of fludarabine, carboplatin, and topotecan in treating patients who have relapsed or refractory acute leukemia or advanced myelodysplastic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: carboplatin Drug: fludarabine phosphate Drug: topotecan hydrochloride||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose of topotecan when administered with carboplatin and fludarabine in patients with refractory or relapsed acute leukemia or advanced myelodysplastic syndrome. II. Determine treatment related and dose limiting toxicities of this regimen in these patients. III. Determine the antileukemia activity of this regimen in these patients. IV. Correlate treatment related toxicities with steady state levels of topotecan in these patients.
OUTLINE: This is a dose escalation study of topotecan. Patients receive carboplatin IV continuously and fludarabine IV over 30 minutes on days 1-5, then topotecan IV continuously on days 6-8. Patients with residual leukemia in the bone marrow at day 15 may receive a second induction course. Patients who achieve partial or complete remission after 1-2 induction courses receive 1 consolidation course of fludarabine, carboplatin, and topotecan beginning 4-8 weeks after recovery from induction therapy. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The first 3 patients do not receive any topotecan. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 6-15 patients will be accrued for this study within 15-21 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Fludarabine, Carboplatin, and Topotecan for Patients With Relapsed/Refractory Acute Leukemia and Advanced Myelodysplastic Syndromes|
|Study Start Date :||September 1998|
|Primary Completion Date :||April 2002|
|Study Completion Date :||March 2003|
- Determine the maximum tolerated dose of topotecan when administered with carboplatin and fludarabine. [ Time Frame: Patients are followed monthly for 6 months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005593
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Brenda W. Cooper, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|