Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.

PURPOSE: This randomized phase II trial is studying 4 different tipifarnib regimens to compare how well they work in treating older patients with acute myeloid leukemia.

Further Study Information

OBJECTIVES:

• Determine the efficacy of 4 different regimens of tipifarnib in older patients with previously untreated acute myeloid leukemia.

• Provide increased access to this drug for these patients.

• Determine the frequency and severity of toxic effects of these regimens in these patients.

• Correlate, preliminarily, response to this drug with cytogenetics and assess whether karyotype represents a potential prognostic factor in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 4 treatment arms.

• Arm I: Patients receive oral tipifarnib twice daily on days 1-21.

• Arm II: Patients receive oral tipifarnib twice daily on days 1-7 and 15-21.

• Arm III: Patients receive tipifarnib as in arm I, but at a lower dose.

• Arm IV: Patients receive tipifarnib as in arm II, but at a lower dose. In all arms, courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Patients who achieve a complete remission (CR) receive up to 3 additional courses beyond CR. Patients in CR who develop recurrent disease after the completion of therapy are eligible to receive tipifarnib again.

Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

PROJECTED ACCRUAL: A total of 60-296 patients (15-74 per treatment arm) will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Morphologically confirmed acute myeloid leukemia (AML) by bone marrow aspiration and biopsy

• No acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia

• Ineligible for or refused standard AML cytotoxic chemotherapy regimens

• Prior myelodysplastic syndromes (MDS) allowed

• Concurrent enrollment on SWOG-9007 (cytogenetics protocol) required (Southwest Oncology Group patients only)

PATIENT CHARACTERISTICS:

Age

• 70 and over

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≤ 30,000/mm^3 (hydroxyurea allowed)

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN) (except when attributed to Gilbert's syndrome or hemolysis)

• AST or ALT ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Other

• Fertile patients must use effective contraception

• Prior malignancy allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior hematopoietic growth factors, thalidomide, or signal transduction inhibitors for MDS allowed

• Concurrent growth factors for MDS allowed

Chemotherapy

• No prior systemic chemotherapy for acute leukemia except hydroxyurea

• No prior AML induction type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support for MDS

• Prior arsenic trioxide, azacitidine, or low-dose (< 100 mg/m^2/day) cytarabine for MDS allowed

• At least 6 months since chemotherapy for a prior malignancy

Endocrine therapy

• Concurrent hormonal therapy allowed

Radiotherapy

• At least 6 months since radiotherapy for a prior malignancy

Surgery

• Not specified

Other

• Recovered from all prior therapy

• Other prior low-intensity therapy for MDS allowed

• No concurrent therapy for MDS (other than growth factors)

• No antacids within 2 hours of tipifarnib administration

• No concurrent enzyme-inducing anticonvulsants, including phenytoin, fosphenytoin, phenobarbital, primidone, carbamazepine, and oxcarbazepine

Trial Contact Information

Trial Lead Organizations/Sponsors

Southwest Oncology Group

Harry Paul Erba

Study Chair

Richard A. Larson

Study Chair

Martin Stuart Tallman

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00093418
Information obtained from ClinicalTrials.gov on January 16, 2012

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