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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005793 |
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.
Condition | Intervention | Phase |
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Leukemia |
Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: topotecan hydrochloride |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of Induction Chemotherapy With Daunorubicin, Cytarabine, Topotecan and Etoposide (DATE) for De Novo AML: In the Treatment of Young Patients Ages 16-60 |
Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of topotecan (phase I) followed by a response rate-determination (phase II) study.
Patients receive induction chemotherapy with daunorubicin IV over 10-15 minutes on days 1-3, cytarabine IV continuously on days 1-5, topotecan IV continuously on days 6-8, and etoposide IV over 60 minutes on days 9 and 10. Within 4 weeks of hematologic recovery, patients achieving remission after induction receive consolidation chemotherapy with cytarabine IV over 1 hour every 12 hours on days 1, 3, and 5. Subsequent courses of consolidation chemotherapy begin within 2 weeks of documentation of hematologic recovery from the prior consolidation course. Consolidation chemotherapy continues for 4 courses in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive induction chemotherapy at the recommended phase II dose.
Patients are followed at 1 month, every 2 months for 1 year, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 3-36 patients (phase I) and then an additional 24-27 patients (phase II) will be accrued for this study within 4 years.
Ages Eligible for Study: | 16 Years to 59 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed, previously untreated acute myeloid leukemia (AML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute | |
Tampa, Florida, United States, 33612-9497 |
Study Chair: | Hussain I. Saba, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000067748, MCC-11941, MCC-IRB-5367, NCI-G00-1751 |
Study First Received: | June 2, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00005793 History of Changes |
Health Authority: | United States: Federal Government |
untreated adult acute myeloid leukemia adult acute erythroid leukemia (M6) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute megakaryoblastic leukemia (M7) |
adult acute monocytic leukemia (M5b) adult acute minimally differentiated myeloid leukemia (M0) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) |
Antimetabolites Leukemia, Monocytic, Acute Daunorubicin Immunologic Factors Acute Myelomonocytic Leukemia Leukemia, Myeloid Acute Monoblastic Leukemia Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Etoposide phosphate Leukemia, Myelomonocytic, Acute |
Anti-Bacterial Agents Leukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Leukemia, Erythroblastic, Acute Acute Myeloid Leukemia, Adult Topotecan Congenital Abnormalities Antineoplastic Agents, Phytogenic Etoposide Cytarabine Di Guglielmo's Syndrome |
Antimetabolites Anti-Infective Agents Daunorubicin Neoplasms by Histologic Type Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Leukemia, Myeloid Antibiotics, Antineoplastic |
Leukemia, Myeloid, Acute Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Leukemia Neoplasms Therapeutic Uses Topotecan Antineoplastic Agents, Phytogenic Etoposide Cytarabine |