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Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003255
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: April 2001

November 1, 1999
July 23, 2008
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Complete list of historical versions of study NCT00003255 on ClinicalTrials.gov Archive Site
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Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia
Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)

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.

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.

PROJECTED ACCRUAL: Up to 38 patients will be accrued for this study within 1.5 years.

Interventional
Phase 2
Primary Purpose: Treatment
Leukemia
  • Drug: carboplatin
  • Drug: topotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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DISEASE CHARACTERISTICS: Previously established diagnosis of acute myelogenous leukemia: Failure to achieve a complete remission with initial induction regimen First relapse within 1 year of initial complete remission Failure to achieve complete remission with one or two courses of reinduction therapy at first relapse Second relapse after no more than two different induction regimens Chemotherapy-related leukemia with unfavorable cytogenetics No active CNS leukemia Not eligible for allogeneic bone marrow transplant from related donor

PATIENT CHARACTERISTICS: Age: 18 to 74 Performance status: ECOG 0-2 Life expectancy: At least 4 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than upper limit of normal (ULN) (unless elevation due to AML) Renal: Creatinine no greater than 0.3 mg/dL above ULN Cardiovascular: No myocardial infarction within the past 3 months No congestive heart failure No poorly controlled cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use adequate contraception No psychosis No active systemic infections

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from the toxic effects of previous chemotherapy At least 3 days since hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No prior or concurrent aminoglycosides or amphotericin B within past 7 days

Both
18 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00003255
CDR0000066143, NCCTG-968151
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: Scott H. Kaufmann, MD, PhD Mayo Clinic
National Cancer Institute (NCI)
April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP