Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Calcitriol may help carboplatin kill more cancer cells by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of carboplatin plus calcitriol in treating patients who have prostate cancer that has not responded to hormone therapy.
Dietary Supplement: calcitriol
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Calcitrol Enhanced Carboplatin in Hormone Refractory Prostate Cancer|
- PSA response rate defined as 50% decrease from baseline, confirmed on a second measurement 4 weeks later [ Designated as safety issue: No ]
|Study Start Date:||December 2000|
|Study Completion Date:||July 2006|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the response in patients with androgen-independent prostate cancer treated with calcitriol and carboplatin. II. Determine the palliative response in patients with cancer-related pain treated with this regimen. III. Determine the response in patients with bidimensionally measurable disease treated with this regimen. IV. Determine the duration of prostate-specific antigen, palliative, and measurable disease responses in patients treated with this regimen. V. Determine the survival of patients treated with this regimen. VI. Assess the quality of life of patients treated with this regimen. VII. Determine the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients receive oral calcitriol on day 1 and carboplatin IV over 60 minutes on day 2. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline and then every 4 weeks until disease progression. Patients are followed every 4 weeks until disease progression and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017576
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97201-3098|
|Study Chair:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|