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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01558492
First received: February 16, 2012
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Carboplatin
Drug: Paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer Previously Treated With Docetaxel

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Change in tumor size [ Time Frame: Baseline, week 12, week 24 and end of study. ] [ Designated as safety issue: No ]
    Assessed by CT or MRI scan and/or bone scan.


Secondary Outcome Measures:
  • Change in survival status [ Time Frame: 6 months, 12 months, 18 months, 24 monhts, 30 months, 36 months, 42 months and 48 monhts. ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All subjects
Carboplatin and Paclitaxel
Drug: Carboplatin
AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
Drug: Paclitaxel
80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
Other Name: Taxol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558492

Contacts
Contact: Himisha Beltran 646-962-2072 hip9004@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical Collgeg Recruiting
New York, New York, United States, 10021
Contact: Gina Mileo, R.N.    212-746-5430    gjm2003@med.cornell.edu   
Principal Investigator: Himisha Beltran, M.D.         
Sub-Investigator: David Nanus, M.D.         
Sub-Investigator: Scott Tagawa, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Himisha Beltran, M.D. Weill Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01558492     History of Changes
Other Study ID Numbers: 1008011188
Study First Received: February 16, 2012
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Metastatic Castrate Resistant Prostate Cancer
CRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014