Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bridgewater, New Jersey 08807


Purpose:

This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy. Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor. All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.


Criteria:

INCLUSION CRITERIA: - patients with prostate cancer who have just undergone prostatectomy, - high risk of their cancer recurring (High risk is defined as at least a 50 percent chance the cancer will return within three years after surgery.) EXCLUSION CRITERIA: - Prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy, or any other anticancer therapy. - Prior radiation therapy - Patients receiving any concurrent therapy for cancer. This includes alternative therapies - Patients requiring concurrent treatment with corticosteroids, with the exception of inhaled and topical corticosteroids. - History of a malignancy other than prostate cancer - Peripheral neuropathy >/= Grade 2 - Psychological, familial, sociological or geographical conditions which do not permit treatment and/or medical follow-up required to comply with the study protocol - Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween 80).


NCT ID:

NCT00069888


Primary Contact:

Study Director
Yasir Nagarwala, M.D.
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.