A Study of Docetaxel Plus Carboplatin in Patients With Hormone Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Male

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 as docetaxel. The investigators are also studying whether the measurement of two proteins in the blood may predict who will respond to the combination of docetaxel and carboplatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Bristol-Myers Squibb; Lowell General Hospital; Massachusetts General Hospital; Oregon Health and Science University; Wentworth-Douglass Hospital
• Treatments: Carboplatin; Docetaxel; Hormones

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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