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Cisplatin, Gemcitabine and Bevacizumab in Combination for Metastatic Transitional Cell Cancer

NCT00234494 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-03-14

Study results available
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Summary

Cisplatin is a very important agent for the treatment of TCC as it has a single agent response rate of approximately 15%. However, it has been most important as a part of combination chemotherapy, MVAC initially and now in combination with gemcitabine. Single agent gemcitabine has demonstrated an overall response rate (ORR) of approximately 25%, including some complete responses (CR), with minimal toxicity in patients with advanced bladder cancer. Bevacizumab, a murine anti-human VEGF monoclonal antibody, has been advanced for use in combination with cytotoxic chemotherapy to delay time to disease progression in patients with metastatic solid tumors.

This trial is designed to further assess the efficacy, safety and tolerability of this regimen in this patient population.

Conditions

Interventions

DRUG

Cisplatin

Cisplatin 70 mg/m2, day 1

DRUG

Gemcitabine

Gemcitabine 1250 mg/m2, day 1 and 8

DRUG

Bevacizumab

Bevacizumab 15mg/kg, day 1

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Christopher Sweeney, MBBS

    lead OTHER

Principal Investigators

  • Christopher Sweeney, M.B.B.S. · Hoosier Oncology Group, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00234494 on ClinicalTrials.gov