A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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/II trial to study the effectiveness of combination chemotherapy in treating patients who have previously untreated acute myeloid leukemia.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI); SmithKline Beecham
• Treatments: Cytarabine; Daunorubicin; Etoposide; Etoposide phosphate; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed, previously untreated acute myeloid leukemia (AML)

• All FAB types, M0-M7, excluding M3

• No AML after myelodysplastic syndrome

PATIENT CHARACTERISTICS:

Age:

• 16 to 59

Performance status:

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin less than 2 mg/dL

• SGOT/SGPT normal unless due to leukemic disease

• Alkaline phosphatase normal unless due to leukemic disease

Renal:

• Creatinine no greater than 2.0 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• Ejection fraction at least 50% by MUGA

• No myocardial infarction or serious ventricular arrhythmia within the past 6 months

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other prior malignancy within the past 5 years except resected skin cancer

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior topotecan or any other DNA topoisomerase I inhibitor (e.g., irinotecan, aminocamptothecin, or nitrocamptothecin) or etoposide for any prior malignancy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified