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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00134706

Run by

Dana-Farber Cancer Institute

People needed

30

Starts

2004-01-01

Expected to finish

2009-09-01

Last updated by the study team

2009-12-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Lowell General Hospital — Lowell, Massachusetts, United States
• Wentworth Douglass Hospital — Dover, New Hampshire, United States
• Oregon Health and Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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