Clinical trial NCT00084825: 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
Official title: Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Cancer
Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
stage IV prostate cancer
bone metastases
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-06-11
Enrollment: 23
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Treatment efficacy
timeFrame: 12 weeks after initiation of crossover therapy
Secondary outcomes:
measure: Time to progression
timeFrame: From registration to disease progression, up to 32 months
measure: Response rate
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Houston
country: United States
facility: M.D. Anderson Cancer Center at University of Texas
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Paul Mathew
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Christopher Logothetis, MD
role: STUDY_CHAIR
References:
citation: 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.