A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)
Overview
- Phase
- Phase 2
- Intervention
- carboplatin
- Conditions
- Prostate Cancer
- Sponsor
- Jonsson Comprehensive Cancer Center
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Time to PSA Progression
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description
OBJECTIVES: * Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin. * Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen. * Determine the safety and toxicity of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must be informed of investigational nature of the study and written informed consent must be obtained prior to study entry
- •Patients \>18 years of age
- •Patients with a histologic diagnosis of adenocarcinoma of the prostate
- •Patients must have metastatic disease with progression despite androgen ablation. Patients who have not undergone orchiectomy must continue LHRH analogues. For patients receiving LHRH analogues their testosterone level must be \< 50ng/dL
- •Patients with bidimensionally measurable disease or bone metastases that is not progressive but who have a rising PSA are eligible
- •Patients with an ECOG performance status \<2
- •Patients must have discontinued flutamide or nilutamide at least 4 weeks prior to the first day of treatment with evidence of progressive disease. Patients must have discontinued bicalutamide at least 6 weeks prior to registration with evidence of progressive disease
- •Patients with adequate hematological, renal, and hepatic function as defined by the following required laboratory values:
- •While blood cell count: \> 3,000/mm3
- •Absolute granulocyte count: \> 1,500/mm3
Exclusion Criteria
- •Patients with biochemical only progression
- •Patients who have received any prior chemotherapy for cancer of the prostate
- •Patients who received antiandrogen therapy within 4 weeks prior to the first day of treatment after cessation of flutamide or nilutamide, and or within 6 weeks prior to registration after cessation of bicalutamide
- •Patients receiving concomitant chemotherapy, biologic therapy, or radiation therapy
- •Patients who have received Strontium 89 or other radioisotope therapies
- •Patients with decreasing PSA levels following antiandrogen withdrawal
- •Patients with \> grade 1 peripheral sensory or motor neuropathy
- •Patients with known carcinomatous meningitis or brain metastases are excluded
- •Patients with past or current histories of neoplasm other than entry diagnosis except for in-situ carcinoma of any site, non-melanoma skin cancer, or other malignancy treated by surgery or radiation with a disease-free survival longer than 5 years
- •Patients who have undergone major surgery \< 3 weeks prior to registration, except for biopsy or placement of a venous access device. Patients must have fully recovered from all effects of any prior surgery
Arms & Interventions
Treatment
Please see intervention descriptions
Intervention: carboplatin
Treatment
Please see intervention descriptions
Intervention: paclitaxel
Outcomes
Primary Outcomes
Time to PSA Progression
Time Frame: Evaluated every 28 days during Treatment Period
In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by \>=5ng/ml, confirmed by a second value at \>=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is \>=5ng/ml and is confirmed by a second value at \>=4 week intervals.
Prostate-specific Antigen (PSA) Response Rate
Time Frame: Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.
PSA response is defined as a decline from the baseline value of \>=50% confirmed by a second PSA value 4 or more weeks later.
Secondary Outcomes
- Objective Response Rate(Evaluated every 12 weeks during Treatment Period)
- Overall Survival Rate(Assessed every two months after completion of study treatment for 4 years)