Carboplatin and Paclitaxel in Patients With Metastatic, Castrate-Resistant Prostate Cancer
This study is currently recruiting participants.
Verified March 2012 by Weill Medical College of Cornell University
Sponsor:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01558492
First received: February 16, 2012
Last updated: March 16, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (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
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
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: | March 16, 2012 |
| 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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013