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Home > "A" Clinical Trials Conditions > A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy  A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
For Condition: Prostate Cancer
Status: Completed
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Open Label, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Male
Protocol Entry Criteria: The trial is for patients with prostate cancer who have just undergone prostatectomy, and are at 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.
Total Enrollment:
Location and Contact Information:
Aventis Oncology
Bridgewater, New Jersey,
United States
Additional Information:
Study ID Numbers: XRP6976J/2501;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069888
Other Prostate Cancer Studies:
1. Phase 1 Single Ascending Dose Trial of MLN2704 in Subjects with Metastatic Androgen Independent Prostate Cancer
2. Treatment of Erectile Dysfunction (ED) in Patients Treated for Prostate Cancer
3. Flavopiridol in Treating Patients With Refractory Cancer
4. ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere
5. ET-743 in Men with Advanced Prostate Cancer
Related Studies:
Other Prostate Cancer Clinical Trials
Other New Jersey Clinical Trials
Other Bridgewater Clinical Trials
A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
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