Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
N/A
N/A
Male
Metastatic Cancer, Prostate Cancer
Trial Information
Crossover From Docetaxel and Placebo to Docetaxel and Imatinib in Patients With Androgen-Independent Prostate Cancer With Bone Metastases: Extension Trial to ID03-0008
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Treatment efficacy
Outcome Time Frame:
12 weeks after initiation of crossover therapy
Safety Issue:
No
Principal Investigator
Paul Mathew
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000365625
NCT ID:
NCT00084825
Start Date:
May 2003
Completion Date:
June 2008
Related Keywords:
- Metastatic Cancer
- Prostate Cancer
- adenocarcinoma of the prostate
- recurrent prostate cancer
- stage IV prostate cancer
- bone metastases
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
- Prostatic Neoplasms
- Bone Neoplasms
- Bone Marrow Diseases
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
