Carboplatin Plus Docetaxel (Taxotere) in Anaplastic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00514540|
Recruitment Status : Completed
First Posted : August 10, 2007
Results First Posted : September 1, 2020
Last Update Posted : September 1, 2020
The goal of this clinical research study is to learn about how effective 2 chemotherapy drugs carboplatin (Paraplatin) plus docetaxel (Taxotere) in the treatment of patients with anaplastic prostate cancer. Patients who continue to have advanced disease will be switched to etoposide (VePesid) plus cisplatin (Platinol-AQ) to study how effective this second line of chemotherapy is in the treatment of patients iwth anaplastic prostate cancer.
The side effects, characteristics of patients who respond, and overall survival will also be studied.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Docetaxel Drug: Carboplatin Drug: Etoposide Drug: Cisplatin||Phase 2|
|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|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: First-Line/Second-Line Chemotherapy
First-Line (CD) Chemotherapy: 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.
Second-Line (EP) Chemotherapy: Etoposide 120 mg/m^2 daily for 3 days and Cisplatin 25 mg/m^2 for 3 days with adequate intravenous hydration mannitol diuresis and supportive care (antiemetics). Repeated every 3 weeks.
75 mg/m^2 IV over 60 Minutes on Day 1 of 21 day cycle.
Other Name: Taxotere
AUC = 5 IV Over 30 Minutes On Day 1 of 21 day cycle.
Other Name: Paraplatin
120 mg/m^2 daily for 3 days of 21 day cycle.
25 mg/m^2 for 3 days of 21 day cycle.
- Median Time to Progression (TTP) [ Time Frame: Baseline to evaluation at end of course 2 (up to 168 days) then every 2 months for disease progression. Follow up every 6 months and overall study period was six and half years. ]TTP defined as time of registration on study till disease progression. Disease status evaluated at the 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 Rate of Salvage Chemotherapy With Etoposide Plus Cisplatin Following Treatment With Docetaxel Plus Carboplatin. [ Time Frame: Evaluated at the 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 rate is the number of participants with response compared to total. Response defined as the absence of disease progression compared to the participant's baseline evaluation, and the time to a serious adverse event (SAE), defined as grade 3 or 4 neurotoxicity or death.
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|