Paclitaxol (Taxol) for Refractory or Relapsed Acute Leukemia in Elderly Patients, and Blast Crisis of Chronic Myelogenous Leukemia: A Multicenter Phase I/II Study
18 Years
75 Years
Both
Leukemia
Trial Information
Paclitaxol (Taxol) for Refractory or Relapsed Acute Leukemia in Elderly Patients, and Blast Crisis of Chronic Myelogenous Leukemia: A Multicenter Phase I/II Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Albert von Rohr, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Klinik Hirslanden
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 34/95
NCT ID:
NCT00003230
Start Date:
January 1998
Completion Date:
July 2000
Related Keywords:
- Leukemia
- 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
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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