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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01558492
• Other study ID #: 1008011188
• Status: Terminated
• Phase: Phase 2
• First received: February 16, 2012
• Last updated: February 1, 2017
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Carboplatin
AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
• Paclitaxel
80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in prostate-specific antigen (PSA) level		Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.
Primary	Change in tumor size	Assessed by CT or MRI scan and/or bone scan.	Baseline, week 12, week 24 and end of study.
Secondary	Change in survival status		6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.