Clinical trial NCT00003230: Paclitaxel in Treating Patients With Refractory or Recurrent Acute Leukemia or Chronic Myelogenous Leukemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Keywords: recurrent adult acute myeloid leukemia
recurrent adult acute lymphoblastic leukemia
blastic phase chronic myelogenous leukemia
untreated adult acute lymphoblastic leukemia
untreated adult acute myeloid leukemia
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2004-07-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL) of B-cell or T-cell type, or blast crisis of chronic myelogenous leukemia (CML) Must fulfill one of the following criteria: - Newly diagnosed, previously untreated AML or ALL in elderly patients (65 75) - First or subsequent relapse of AML or ALL after standard chemotherapy, autologous or allogeneic bone marrow transplantation, or high-dose treatment with peripheral blood stem cell support - AML or ALL that is refractory to standard chemotherapy (no complete remission achieved after 2 courses of conventional induction chemotherapy) - CML in blast crisis of any subtype (i.e., myelogenous or lymphoblastic) with or without previously known chronic phase No leukemic involvement of the central nervous system

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: WHO 0-3 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: Creatinine less than 1.25 times ULN Cardiovascular: No history of atrial or ventricular arrhythmias No history of congestive heart failure, even if medically controlled No history of documented myocardial infarction Neurologic: No motor or sensory neuropathy grade 2 or more No dementia or significantly altered mental status Other: HIV negative No active infection or other serious underlying medical condition No prior allergic reaction to a drug containing Cremophor EL No complete bowel obstruction Not pregnant or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No required concurrent cytoreductive treatment in addition to paclitaxel No concurrent growth factors or cytokine No concurrent immunotherapeutic drugs Chemotherapy: No prior paclitaxel or related compounds for a malignancy other that leukemia No required concurrent cytoreductive treatment in addition to paclitaxel Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonspital Aarau
city: Basel
country: Switzerland
facility: Office of Walter Weber-Stadelman
city: Basel
country: Switzerland
facility: University Hospital
city: Bern
country: Switzerland
facility: Inselspital, Bern
city: Geneva
country: Switzerland
facility: Hopital Cantonal Universitaire de Geneva
city: Lugano
country: Switzerland
facility: Istituto Oncologico della Svizzera Italiana
city: Solothurn
country: Switzerland
facility: Burgerspital, Solothurn
city: Zurich
country: Switzerland
facility: City Hospital Triemli
city: Zurich
country: Switzerland
facility: Klinik Hirslanden
Study officials:
affiliation: Klinik Hirslanden, Zurich
name: Albert von Rohr, MD
role: STUDY_CHAIR
References: