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

NCT01558492 | Terminated Phase 2 Results DMC

• 1 other identifier: 1008011188
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Metastatic Castrate Resistant Prostate Cancer; CRPC

Outcome Measures

Primary Outcomes (2)

• Change in Prostate-specific Antigen (PSA) Level

  Baseline, week 4, week 8, week 12, week 16, week 20, week 24 and end of study.

• Change in Tumor Size

  Assessed by CT or MRI scan and/or bone scan.

  Baseline, week 12, week 24 and end of study.

Secondary Outcomes (1)

• Change in Survival Status

  6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months and 48 months.

Study Arms (1)

All subjects

EXPERIMENTAL

Carboplatin and Paclitaxel

Drug: Carboplatin; Drug: Paclitaxel

Interventions

Carboplatin DRUG

AUC = 5 intravenously (IV) on day 1 of a 28 day cycle

Also known as: Paraplatin

All subjects

Paclitaxel DRUG

80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle

Also known as: Taxol

All subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Results Point of Contact

• Title: Himisha Beltran, MD
• Organization: Weill Cornell Medicine

hip9004@med.cornell.edu

646-962-2072

Study Officials

• Himisha Beltran, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: March 20, 2012
• Study Start: March 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: November 1, 2013
• Last Updated: June 9, 2017
• Results First Posted: April 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)