Carboplatin Plus Topotecan in Treating Patients With Relapsed Acute Myelogenous Leukemia

NCT00003255 | Completed Phase 2

• 2 other identifiers: NCCTG-968151CDR0000066143
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; secondary acute myeloid leukemia

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 5 years

Study Arms (1)

topotecan + carboplatin

EXPERIMENTAL

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: carboplatin; Drug: topotecan hydrochloride

Interventions

carboplatin DRUG

topotecan + carboplatin

topotecan hydrochloride DRUG

topotecan + carboplatin

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

Carboplatin; Topotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Scott H. Kaufmann, MD, PhD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 20, 2004
• Study Start: November 1, 1999
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 12, 2016

Record last verified: 2016-07