Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00514540|
Recruitment Status : Completed
First Posted : August 10, 2007
Last Update Posted : January 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Docetaxel Drug: Carboplatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Carboplatin Plus Docetaxel (Taxotere) in Patients With Anaplastic Prostate Carcinoma|
|Study Start Date :||May 2006|
|Primary Completion Date :||April 2013|
|Study Completion Date :||April 2013|
Experimental: Carboplatin + Docetaxel
Carboplatin area under the curve (AUC) = 5, intravenous (IV) over 30 minutes and Docetaxel 75 mg/m^2 IV over 60 minutes, Day 1 repeated every 3 weeks.
75 mg/m^2 IV Over 60 Minutes On Day 1 Repeat Every 3 Weeks.
Other Name: TaxotereDrug: Carboplatin
AUC = 5 IV Over 30 Minutes On Day 1 repeat every 3 weeks.
Other Name: Paraplatin
- Response Rate [ Time Frame: Response evaluated at end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1). ]Response evaluated at end of course 1 (up to 84 days after day 1 of cycle 1) and at the end of course 2 (up to 168 days after day 1 of cycle 1). Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response: disappearance of all target lesions. Partial Response: > 30% decrease in sum longest diameter of target lesions, reference baseline sum longest diameter; Progressive Disease: >20% increase in sum of longest diameter target lesions, reference smallest sum longest diameter recorded since treatment started or appearance of 1/> new lesions. Stable Disease: Insufficient shrinkage to qualify as partial response, or insufficient increase to qualify for progressive disease, reference smallest sum longest diameter since treatment started.
- Median Overall Survival [ Time Frame: Baseline (start of treatment) to disease progression or death for any reason, up to 5 years of follow up. ]From the date of treatment to the date of death and to the date of last follow-up for those still alive. Survival updates taken at 6 month intervals from the offstudy date.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514540
|United States, California|
|University of California-San Francisco|
|San Francisco, California, United States, 94143|
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ana M. Aparicio, MD||M.D. Anderson Cancer Center|