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

Randomized Double-Blind Phase II Trial of Docetaxel and Imatinib Versus Docetaxel and Placebo in Metastatic Androgen-Independent Prostate Cancer (AIPC) With Bone Metastases

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00080678
Enrollment
116
Registered
2004-04-08
Start date
2003-05-31
Completion date
2008-03-31
Last updated
2012-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer, Prostate Cancer

Keywords

adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer, bone metastases

Brief 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.

Detailed 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.

Interventions

DRUGDocetaxel
DRUGImatinib Mesylate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Time to progressionBaseline to 3 years, or until disease progression

Secondary

MeasureTime frame
Response rateUp to 3 years
Toxic effects3 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026