A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients
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|ClinicalTrials.gov Identifier: NCT00675545|
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : April 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hormone-Refractory Prostate Cancer||Drug: Docetaxel, Carboplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Docetaxel Plus Carboplatin in Chemonaive Hormone-Refractory Prostate Cancer (HRPC) Patients|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Experimental: docetaxel and prednisolone
Patients in study will receive both chemotherapeutic agents on day 1 and day 8 of every 21-day cycle as described below:
Drug: Docetaxel, Carboplatin
Docetaxel Form: A white, lyophilized powder in vials of 50, 150, and 450 mg each, which should be stored at room temperature in a light-protected area.
Carboplatin Form: Taxotere is supplied as a sterile, non-aqueous, viscous solution with an accompanying sterile diluent (13% ethanol in water for injection). 20 and 80 mg strengths are available.
- efficacy of docetaxel plus carboplatin [ Time Frame: evaluated every 3 cycles (9 weeks) ]The primary endpoint of the study is best overall response (complete or partial response) obtained from measurable target lesion or PSA, as defined using the modified RECIST criteria.
- duration of response and toxicity profile of docetaxel and carboplatin. [ Time Frame: during patient's treatment ]
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): NCT00675545
|National University Hospital|
|Principal Investigator:||Alvin Wong, MD||National University Hospital, Singapore|