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

NCT ID: NCT01558492

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-11-30

Brief Summary

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

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

All subjects

Carboplatin and Paclitaxel

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

AUC = 5 intravenously (IV) on day 1 of a 28 day cycle

Paclitaxel

Intervention Type: DRUG

80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle

Interventions

Carboplatin

AUC = 5 intravenously (IV) on day 1 of a 28 day cycle

Intervention Type: DRUG

Paclitaxel

80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle

Intervention Type: DRUG

Other Intervention Names

Paraplatin; Taxol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Himisha Beltran, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

1008011188

Identifier Type: -

Identifier Source: org_study_id