Status:
COMPLETED
A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Beth Israel Deaconess Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to look at the effects (good and bad) of the combination of docetaxel and carboplatin for patients who have progressive prostate cancer after chemotherapy with drugs such ...
Detailed Description
Patients will receive both carboplatin and docetaxel. This treatment is given in the outpatient department once every 3 weeks (called one cycle). One day prior to the day of chemotherapy, patients ar...
Eligibility Criteria
Inclusion
- Histologically confirmed adenocarcinoma of the prostate
- Evidence of metastatic disease
- Disease progression following androgen deprivation therapy
- Disease progression despite docetaxel-based chemotherapy
- Serum testosterone levels less than 50ng/ml (unless surgically castrated). Patients must continue androgen deprivation with a luteinizing hormone-releasing hormone (LHRH) analogue if they have not undergone orchiectomy.
- No use of antiandrogens for at least 4 weeks
- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
- Acceptable white blood cell (WBC), platelets, creatinine and AST counts
Exclusion
- Significant peripheral neuropathy defined as grade 2 or higher
- Within 4 weeks since completing external beam radiotherapy or 8 weeks since completing radiopharmaceutical therapy (strontium, samarium)
- Prior platinum-based chemotherapy (cisplatin or carboplatin) for hormone- refractory prostate cancer
- Concomitant chemotherapy, investigational agents or systemic steroids
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00134706
Start Date
January 1 2004
End Date
September 1 2009
Last Update
December 9 2009
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Lowell General Hospital
Lowell, Massachusetts, United States, 01854