Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00003230|
Recruitment Status : Completed
First Posted : July 8, 2004
Last Update Posted : May 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: paclitaxel||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Official Title:||Paclitaxol (Taxol) for Refractory or Relapsed Acute Leukemia in Elderly Patients, and Blast Crisis of Chronic Myelogenous Leukemia: A Multicenter Phase I/II Study|
|Study Start Date :||January 1998|
|Actual Primary Completion Date :||July 2000|
|Actual Study Completion Date :||July 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003230
|Aarau, Switzerland, 5001|
|Office of Walter Weber-Stadelman|
|Basel, Switzerland, CH 4051|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Hopital Cantonal Universitaire de Geneva|
|Geneva, Switzerland, CH-1211|
|Istituto Oncologico della Svizzera Italiana|
|Lugano, Switzerland, CH-6900|
|Solothurn, Switzerland, 4500|
|City Hospital Triemli|
|Zurich, Switzerland, 8063|
|Zurich, Switzerland, CH-8008|
|Study Chair:||Albert von Rohr, MD||Klinik Hirslanden, Zurich|