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Study of Bevacizumab and Erlotinib for Patients With Hormone Refractory Prostate Cancer

NCT00996502 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-03-27

Study results available
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Summary

The primary objectives of this study are to evaluate the safety and best dose of a regimen including bevacizumab and erlotinib in combination with docetaxel and prednisone. In addition, the investigators wish to evaluate how well these drugs might work against this disease. Bevacizumab and erlotinib are novel drugs that attack the blood vessels supplying the tumor cells and attack a receptor on the tumor cells, respectively. This study has two parts. In the first part of the study, eighteen patients will be enrolled. Patients will receive escalating doses of docetaxel in combination with standard doses of bevacizumab and erlotinib until the safest dose is determined. An additional 37 patients will enter into the second part of the study and all will receive the safest dose. In this part of the study, the effectiveness of this regimen against hormone refractory prostate cancer (HRPC) will be monitored by evaluating prostate-specific antigen (PSA) and objective response of the tumor.

Conditions

Interventions

DRUG

Docetaxel

Phase I: * Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle * Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle

DRUG

Bevacizumab

15mg/kg of Bevacizumab every 3 weeks

DRUG

Erlotinib

200 mg of Erlotinib PO daily days 2-16

DRUG

Prednisone

5 mg of Prednisone PO bid

Sponsors & Collaborators

Principal Investigators

  • Daniel P Petrylak, MD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00996502 on ClinicalTrials.gov