Expired Study
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Los Angeles, California 90095


Purpose:

RATIONALE: BAY 43-9006 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. PURPOSE: This phase II trial is studying how well BAY 43-9006 works in treating patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia.


Study summary:

OBJECTIVES: Primary - Determine the major hematologic response rate (complete and partial response) in patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia. - Determine the safety of this drug in these patients. Secondary - Determine the cytogenetic response rate in patients treated with this drug. - Determine the duration of hematologic response in patients treated with this drug. - Determine the duration of cytogenetic response in patients treated with this drug. - Determine time to progression in patients treated with this drug. - Determine overall survival of patients treated with this drug. Tertiary - Determined the molecular response in patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive oral BAY 43-9006 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase - Documented hematologic resistance to imatinib mesylate after a prior hematologic response to imatinib mesylate administered at doses of at least 400 mg/day for at least 3 months - Documentation of resistance requires at least 2 measurements of WBC > 20,000/mm^3 within 2 weeks PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 16 weeks Hematopoietic - See Disease Characteristics - WBC > 20,000/mm^3 Hepatic - Bilirubin ≤ 2.0 times upper limit of normal (ULN) - ALT and AST ≤ 3 times ULN - PT (or INR) and PTT < 1.5 times ULN - No chronic hepatitis B or C Renal - Creatinine ≤ 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV congestive heart failure - No cardiac arrhythmia requiring antiarrhythmics (excluding beta blockers or digoxin) - No active coronary artery disease or ischemia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception - HIV negative - No active clinically serious infection - No known or suspected allergy to study drugs - No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or superficial bladder tumors (Ta, Tis, or T1) - No substance abuse or medical, psychological, or social condition that would preclude study participation - No other concurrent severe disease or comorbidity that would preclude study participation - No other unstable condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - More than 2 weeks since prior interferon - More than 4 weeks since prior anticancer immunotherapy and recovered - No prior allogeneic bone marrow or peripheral blood stem cell transplantation - No concurrent bone marrow transplantation or stem cell rescue Chemotherapy - More than 2 days since prior hydroxyurea - More than 2 weeks since prior cytarabine at a dose < 100 mg - More than 4 weeks since prior cytarabine at a dose > 100 mg - More than 4 weeks since other prior anticancer chemotherapy (6 weeks for nitrosoureas, mitomycin, or busulfan) and recovered - No concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - No prior solid organ allograft - More than 4 weeks since prior significant surgery Other - More than 2 days since prior imatinib mesylate - More than 4 weeks since prior investigational drugs - Concurrent therapeutic anticoagulation (e.g., warfarin or heparin) allowed as long as no underlying abnormality exists - No concurrent antiepileptic drugs for seizure disorders - No concurrent ketoconazole, itraconazole, or ritonavir - No concurrent products containing grapefruit juice - No other concurrent anticancer therapy - No other concurrent investigational drugs


NCT ID:

NCT00085007


Primary Contact:

Principal Investigator
Ronald Paquette, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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