NCT00003230

Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia

Paclitaxol (Taxol) for Refractory or Relapsed Acute Leukemia in Elderly Patients, and Blast Crisis of Chronic Myelogenous Leukemia: A Multicenter Phase I/II Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II 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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	paclitaxel

Timeline

• Start date: 1998-01-01
• Primary completion: 2000-07-01
• Completion: 2000-07-01
• First posted: 2004-07-08
• Last updated: 2012-05-15

Locations

9 sites across 1 country: Switzerland