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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Paclitaxel
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Metastatic Castrate Resistant Prostate Cancer, CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

Carboplatin and Paclitaxel

Outcomes

Primary Outcome Measures

Change in Prostate-specific Antigen (PSA) Level
Change in Tumor Size
Assessed by CT or MRI scan and/or bone scan.

Secondary Outcome Measures

Change in Survival Status

Full Information

First Posted
February 16, 2012
Last Updated
May 5, 2017
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01558492
Brief Title
Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
Official Title
A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
March 2011 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Metastatic Castrate Resistant Prostate Cancer, CRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
Carboplatin and Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Primary Outcome Measure Information:
Title
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.
Title
Change in Tumor Size
Description
Assessed by CT or MRI scan and/or bone scan.
Time Frame
Baseline, week 12, week 24 and end of study.
Secondary Outcome Measure Information:
Title
Change in Survival Status
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Himisha Beltran, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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