A Phase II Trial of Oxaliplatin and Pemetrexed in Hormone Refractory Prostate Cancer
PRIMARY OBJECTIVES: I. To determine the response rate by Response Evaluation Criteria In
Solid Tumors (RECIST) criteria, prostate-specific antigen (PSA) response by the PSA Working
Group criteria, and overall clinical benefit defined by summation of RECIST complete
responses (CR) plus RECIST partial responses (PR) plus PSA PRs. SECONDARY OBJECTIVES: I.
To determine time to progression in patients with hormone-refractory prostate cancer (HRPC)
receiving oxaliplatin and pemetrexed. II. To describe the safety profile of this treatment.
III. Pain response will be evaluated in an exploratory manner. IV. Undertake a pilot
analysis of excision repair cross-complementing 1 (ERCC1) expression levels and
polymorphisms, looking at their ability to predict response to platinum therapy. OUTLINE:
Patients receive oxaliplatin intravenously (IV) over 2 hours and pemetrexed disodium IV on
day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression
or unacceptable toxicity. After completion of study treatment, patients are followed up
every 6 months.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response in patients with HRPC who have received taxane-based chemotherapy
For patients with measurable disease, the RECIST criteria will be used to determine response; for patients who do not have measurable disease by RECIST, the response will be based on PSA
Baseline after every 2 courses, and then every 6 months after off-study (RECIST); or baseline, day 1 of each course, at the final evaluation, and then every 6 months after off-study (PSA)
USC/Norris Comprehensive Cancer Center
United States: Federal Government
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|