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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Administered Day 1 of each cycle. AUC=6.
administered Days 1, 8, and 15 of each cycle. 100mg/m2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Prostate-specific Antigen (PSA) Response Rate
PSA response is defined as a decline from the baseline value of \>=50% confirmed by a second PSA value 4 or more weeks later.
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.
Time to PSA Progression
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.
Time frame: Evaluated every 28 days during Treatment Period
Objective Response Rate
Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \<50% and lesions with an estimated increase of \<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \>=25% or appearance of new lesions. Need for radiotherapy is considered PD.
Time frame: Evaluated every 12 weeks during Treatment Period
Overall Survival Rate
Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of \<50% and lesions with an estimated increase of \<25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be \>=25% or appearance of new lesions. Need for radiotherapy is considered PD.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Assessed every two months after completion of study treatment for 4 years