Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003230
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Paclitaxol Taxol for Refractory or Relapsed Acute Leukemia in Elderly Patients and Blast Crisis of Chronic Myelogenous Leukemia A Multicenter Phase III Study
Status:
COMPLETED
Status Verified Date:
2012-05
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 tumor cells from dividing so they stop growing or die
PURPOSE Phase III trial to study the effectiveness of paclitaxel in treating patients with refractory or recurrent acute leukemia or chronic myelogenous leukemia
PURPOSE Phase III trial to study the effectiveness of paclitaxel in treating patients with refractory or recurrent acute leukemia or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of paclitaxel given as a 96-hour infusion in patients with acute leukemia refractory to or recurrent after standard chemotherapy in patients with blast crisis of chronic myelogenous leukemia or in elderly patients 65-75 with newly diagnosed acute leukemia II Determine the rate of complete and partial remissions to paclitaxel treatment in these patients III Assess the toxic effects of paclitaxel given as a 96-hour infusion in these patients IV Determine the duration of remission after paclitaxel treatment in these patient populations
OUTLINE This is a dose escalation multicenter study Patients receive paclitaxel as a 96-hour continuous infusion Patients may receive a second course of treatment after 4 weeks in the absence of unacceptable toxicity irrespective of the treatment results after 1 course Cohorts of 3 patients are treated at escalating doses of paclitaxel in the absence of dose limiting toxicity DLT If 1 out of 3 patients develops DLT then 3 additional patients are treated at the same dose level If DLT occurs in more than 1 out of 3-6 patients dose escalation stops and this is considered the maximum tolerated dose MTD Once the MTD has been defined the next patients are entered at the dose level preceding the MTD for the phase II portion of the study Patient are followed at 2 weeks after completion of study and then every 3-6 months thereafter
PROJECTED ACCRUAL There will be a total of 33 patients accrued 22 patients in the first stage and 11 in the second stage in this study
OUTLINE This is a dose escalation multicenter study Patients receive paclitaxel as a 96-hour continuous infusion Patients may receive a second course of treatment after 4 weeks in the absence of unacceptable toxicity irrespective of the treatment results after 1 course Cohorts of 3 patients are treated at escalating doses of paclitaxel in the absence of dose limiting toxicity DLT If 1 out of 3 patients develops DLT then 3 additional patients are treated at the same dose level If DLT occurs in more than 1 out of 3-6 patients dose escalation stops and this is considered the maximum tolerated dose MTD Once the MTD has been defined the next patients are entered at the dose level preceding the MTD for the phase II portion of the study Patient are followed at 2 weeks after completion of study and then every 3-6 months thereafter
PROJECTED ACCRUAL There will be a total of 33 patients accrued 22 patients in the first stage and 11 in the second stage in this study
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 |
|---|---|---|---|
| EU-97038 | None | None | None |
| SWS-SAKK-3495 | None | None | None |