Prostate Cancer Clinical Trial

Docetaxel With or Without Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining docetaxel with imatinib mesylate may be effective treatment for androgen-independent prostate cancer and bone metastases.

PURPOSE: This randomized phase II trial is studying docetaxel and imatinib mesylate to see how well they work compared to docetaxel alone in treating patients with androgen-independent prostate cancer and bone metastases.

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Full Description

OBJECTIVES:

Primary

Compare time to progression in patients with androgen-independent prostate cancer and bone metastases treated with docetaxel with vs without imatinib mesylate.

Secondary

Compare the response rates in patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.
Compare quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to hemoglobin (< 11g/dL vs ≥ 11 g/dL), alkaline phosphatase (normal vs elevated), number of prior regimens (0 vs 1 or 2), and ECOG performance score (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive docetaxel IV on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-43.
Arm II: Patients receive docetaxel as in arm I and oral placebo once daily on days 1-43.

In both arms, courses repeat every 43 days in the absence of disease progression or unacceptable toxicity. Patients who progress on arm II may cross over to arm I.

PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of adenocarcinoma of the prostate

Osseous metastases confirmed by radiography
Lytic bone lesions considered for biopsy if there is clinical suspicion of histologic conversion to small cell carcinoma
Failed prior hormonal therapy

Progressive disease, as evidenced by one of the following:

2 consecutive rises in prostate-specific antigen (PSA) of at least 1 ng/mL over 4 weeks
Increase of 25% of the product of bidimensional disease or 30% in maximum diameter
Increase in number of osseous metastases by bone scan
Worsening symptoms attributable to disease progression (e.g., worsening bony pain)
PSA ≥ 1 ng/mL

Castrate serum testosterone ≤ 50 ng/dL

Concurrent luteinizing-hormone releasing-hormone analog required for medically castrated patients
No small cell or sarcomatoid prostate cancers
No uncontrolled CNS metastases

PATIENT CHARACTERISTICS:

Age

Any age

Performance status

Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

At least 3 months

Hematopoietic

Absolute granulocyte count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

Bilirubin ≤ 1.5 mg/dL
Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤ 2 times upper limit of normal
No chronic liver disease

Renal

Creatinine clearance ≥ 40 mL/min

Cardiovascular

No New York Heart Association class III or IV congestive heart failure
No unstable angina
No myocardial infarction within the past 6 months
No evidence of myocardial ischemia on electrocardiogram
No uncontrolled severe hypertension

Pulmonary

No oxygen-dependent lung disease

Other

HIV negative
No concurrent severe infection
No contraindication to corticosteroids
No uncontrolled diabetes mellitus
No grade 2 or greater peripheral neuropathy
No other malignancy within the past 2 years except nonmelanoma skin cancer
No overt psychosis, mental disability, or incompetency that would preclude giving informed consent
No history of noncompliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunotherapy

Chemotherapy

No prior taxanes
No more than 2 prior chemotherapy regimens
At least 30 days since prior chemotherapy and recovered
No other concurrent chemotherapy

Endocrine therapy

See Disease Characteristics
At least 4 weeks since prior flutamide or nilutamide*
At least 6 weeks since prior bicalutamide* NOTE: *Unless there is evidence of interim disease progression

Radiotherapy

At least 90 days since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium and recovered
At least 30 days since other prior radiotherapy and recovered

Surgery

Fully recovered from prior surgery

Other

No concurrent ketoconazole
No concurrent warfarin

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

116

Study ID:

NCT00080678

Recruitment Status:

Completed

Sponsor:

M.D. Anderson Cancer Center

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There are 3 Locations for this study

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Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
M.D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

116

Study ID:

NCT00080678

Recruitment Status:

Completed

Sponsor:


M.D. Anderson Cancer Center

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