Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to look at the clinical benefit of carboplatin and paclitaxel and correlate response to study treatment with biologic parameters (i.e. lab studies of blood, urine, or tissue). It is hoped that this will allow researchers to gain insight into the underlying biology of prostate tumor progression and perhaps predict which patients may benefit from this chemotherapy regimen.

Detailed Description
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Docetaxel/prednisone is the standard of care in patients with metastatic, castrate-resistant prostate cancer (CRPC) but duration of response is limited, with median time to prostate-specific antigen (PSA) progression of 6-8 months. There is currently no standard second-line therapy for patients who have progressed after receiving docetaxel. Carboplatin and paclitaxel have demonstrated activity, but prospective clinical trials evaluating this regimen are limited. In addition, correlative studies investigating why some patients respond are lacking.

Official Title
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A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologic or cytologic diagnosis of prostate carcinoma. Subject must have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy. Furthermore, if applicable, medical castration must be maintained for the duration of the protocol. Serum testosterone < 50 ng/ml. Subjects who have received anti-androgen therapy with a resulting PSA decline must demonstrate progression following discontinuation of anti-androgen therapy. Subjects capable of fathering children must agree to use an effective method of contraception for the duration of the trial. Must have previously received docetaxel for prostate cancer ECOG performance status 0-2 Willing and able to give informed consent Exclusion Criteria: Platelet count <100,000/mm3 Absolute neutrophil count (ANC) <1,500/mm3 Hemoglobin < 8 g/dL Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x upper limit of normal Bilirubin (total) >2 x upper limit of normal. Subjects with known Gilbert's syndrome are eligible if direct bilirubin is within normal limits For subjects with serum creatinine > 1.5 x ULN, calculated creatinine clearance < 30 ml/min are excluded; subjects meeting this exclusion criterion are eligible if a measured clearance is > 30 ml/min Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study Prior investigational therapy within 4 weeks of treatment. Furthermore, other investigational anti-cancer therapy is not permitted during the treatment phase. Grade > 1 peripheral neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>Carboplatin and Paclitaxel | Drug: Carboplatin<br>* AUC = 5 intravenously (IV) on day 1 of a 28 day cycle<br>* Other names: Paraplatin;Drug: Paclitaxel<br>* 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle<br>* Other names: Taxol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Prostate-specific Antigen (PSA) Level |  | Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study. | 
| Change in Tumor Size | Assessed by CT or MRI scan and/or bone scan. | Baseline, week 12, week 24 and end of study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Survival Status |  | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Castrate Resistant Prostate Cancer, CRPC