Docetaxel and Imatinib Mesylate in Treating Patients With Androgen-Independent Prostate Cancer and Bone Metastases That Progressed on the Docetaxel and Placebo Group of MDA-ID-030008

NCT ID: NCT00084825

Last Updated: 2012-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-05-31
• Study Completion Date: 2008-06-30

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. Giving docetaxel with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel with imatinib mesylate works in treating patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and a placebo on clinical trial MDA-ID-030008.

Detailed Description

OBJECTIVES:

Primary

• Provide treatment with docetaxel and imatinib mesylate for patients with androgen-independent prostate cancer and bone metastases that progressed while receiving docetaxel and placebo on MDA-ID-030008.

Secondary

• Determine the response rate and time to progression in these patients after crossover from docetaxel and placebo to docetaxel and imatinib mesylate.
• Compare the modulation of the platelet-derived growth factor receptor pathway by docetaxel and imatinib mesylate vs docetaxel and placebo in the same patient.
• Determine the quality of life of patients treated with this crossover regimen.

OUTLINE: This is an open-label, crossover, multicenter, extension study. Patients who progressed on the placebo and docetaxel arm of MDA-ID-030008 crossover to receive docetaxel and imatinib mesylate.

Patients receive docetaxel IV over 1 hour on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each therapy course, and at the completion of therapy.

Patients are followed for 30 days.

PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study within 9 months.

Conditions

Metastatic Cancer; Prostate Cancer

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel + Imatinib Mesylate

Docetaxel intravenous (IV) over 1 hour on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-42. Courses repeat every 42 days.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

30 mg/m\^2 IV on days 1, 8, 15, and 22 every 42 days

Imatinib mesylate

Intervention Type: DRUG

600 mg orally daily

Interventions

Docetaxel

30 mg/m\^2 IV on days 1, 8, 15, and 22 every 42 days

Intervention Type: DRUG

Imatinib mesylate

600 mg orally daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of adenocarcinoma of the prostate

• Osseous metastases
• Androgen-independent disease
• Previously randomized to the docetaxel and placebo arm of protocol MDA-ID-030008 and has been removed from protocol due to disease progression

• No more than 6 weeks since final treatment with docetaxel and placebo
• No uncontrolled brain metastases or spinal cord compression

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-3

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 75,000/mm^3

Hepatic

• Bilirubin ≤ 1.5 mg/dL
• alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 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 uncontrolled severe hypertension
• No myocardial infarction within the past 6 months

Pulmonary

• No oxygen-dependent lung disease

Other

• No prior dose-limiting toxicity with docetaxel requiring more than 2 dose reductions
• No severe hypersensitivity to docetaxel
• No prior dose-limiting toxicity with docetaxel requiring 1 dose reduction AND experienced recurrent grade 3 or 4 toxicity at the time of progression on MDA-ID-030008
• No uncontrolled diabetes mellitus
• No concurrent severe infection
• No overt psychosis, mental disability, or other incompetency that would preclude giving informed consent
• No history of non-compliance
• HIV negative
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent biologic therapy

Chemotherapy

• See Disease Characteristics
• No other concurrent chemotherapy

Endocrine therapy

• No concurrent second-line hormonal therapy

Radiotherapy

• At least 3 weeks since prior radiotherapy
• No recent strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium

Surgery

• Recovered from prior surgery

Other

• No other concurrent anticancer agents
• No other concurrent investigational agents
• No concurrent therapeutic warfarin

• Concurrent mini-dose warfarin (1 mg/day) for central venous catheter prophylaxis allowed
• No concurrent grapefruit or grapefruit juice

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Mathew

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Christopher Logothetis, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

References

Mathew P, Thall PF, Johnson MM, et al.: Preliminary results of a randomized placebo-controlled double-blind trial of weekly docetaxel combined with imatinib in men with metastatic androgen-independent prostate cancer (AIPC) and bone metastases (BM). [Abstract] J Clin Oncol 24 (Suppl 18): A-4562, 232s, 2006.

Reference Type: RESULT

Related Links

http://www.mdanderson.org

UT MD Anderson Cancer Center Official Website

Other Identifiers

MDA-ID-030222

Identifier Type: -

Identifier Source: secondary_id

MSKCC-03149

Identifier Type: -

Identifier Source: secondary_id

ID03-0222

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000365625

Identifier Type: -

Identifier Source: org_study_id