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

May 5, 2017 updated by: Weill Medical College of Cornell University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All subjects
Carboplatin and Paclitaxel
Drug: Carboplatin
AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Other Names:
  • Paraplatin
Drug: Paclitaxel
80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Himisha Beltran, M.D., Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008011188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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