Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005793
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2000-06-02
Brief Title:
A Phase III Study of Induction Chemotherapy With Daunorubicin Cytarabine Topotecan and Etoposide
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase III Study of Induction Chemotherapy With Daunorubicin Cytarabine Topotecan and Etoposide DATE for De Novo AML In the Treatment of Young Patients Ages 16-59
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 III trial to study the effectiveness of combination chemotherapy in treating patients who have previously untreated acute myeloid leukemia
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have previously untreated acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of topotecan when combined with daunorubicin cytarabine and etoposide in patients with de novo acute myeloid leukemia
Determine the efficacy of this regimen at the MTD of topotecan by measuring the complete response rate in this patient population
Determine the days of hospitalization and number of infections associated with this regimen in these patients
Correlate serum levels of topotecan and etoposide with the expression of topoisomerase I and II in tumor cells and in peripheral blood mononuclear cells PBMN as well as with toxicity and response rate in these patients
Correlate tumor cell and PBMN expression and activity of topoisomerase I and II with hematological toxicity and clinical response in these patients
Correlate levels of activation of STAT signaling proteins with expression of bcl-2 family proteins and response to chemotherapy in these patients
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
Determine the maximum tolerated dose MTD of topotecan when combined with daunorubicin cytarabine and etoposide in patients with de novo acute myeloid leukemia
Determine the efficacy of this regimen at the MTD of topotecan by measuring the complete response rate in this patient population
Determine the days of hospitalization and number of infections associated with this regimen in these patients
Correlate serum levels of topotecan and etoposide with the expression of topoisomerase I and II in tumor cells and in peripheral blood mononuclear cells PBMN as well as with toxicity and response rate in these patients
Correlate tumor cell and PBMN expression and activity of topoisomerase I and II with hematological toxicity and clinical response in these patients
Correlate levels of activation of STAT signaling proteins with expression of bcl-2 family proteins and response to chemotherapy in these patients
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA 82533 | OTHER | NCI | None |