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
  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 II trial to study the effectiveness of combining carboplatin and topotecan in treating patients with relapsed acute myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: carboplatin
Drug: topotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Continuous Infusion Carboplatin and Topotecan in the Treamtment of Relapsed Acute Myelogenous Leukemia (AML)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003255

Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Scott H. Kaufmann, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003255     History of Changes
Other Study ID Numbers: CDR0000066143, NCCTG-968151
Study First Received: November 1, 1999
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Carboplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 22, 2014