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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Christopher Sweeney, MBBS
Study ID
NCT00234494
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cisplatin — DRUG
    Cisplatin 70 mg/m2, day 1
  • Gemcitabine — DRUG
    Gemcitabine 1250 mg/m2, day 1 and 8
  • Bevacizumab — DRUG
    Bevacizumab 15mg/kg, day 1

Study Details

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.

Key Dates

First listed
Oct 7, 2005
Start date
Nov 30, 2005
Status verified
Feb 2016
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Group Assignment
    Cisplatin + Gemcitabine + Bevacizumab

Primary Outcome Measure

Progression Free Survival [ Time Frame: 36 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Medical & Surgical Specialists, LLCGalesburgIllinois61401-
Oncology Hematology Associates of SW IndianaEvansvilleIndiana47714-
Fort Wayne Oncology & Hematology, IncFort WayneIndiana46815-
Indiana University Cancer CenterIndianapolisIndiana46202-
Quality Cancer Center (MCGOP)IndianapolisIndiana46202-
Arnett Cancer CareLafayetteIndiana47904-
Northern Indiana Cancer Research ConsortiumSouth BendIndiana46601-
AP&S ClinicTerre HauteIndiana47804-
Siteman Cancer CenterSt LouisMissouri63110-
Oncology Hematology Care, Inc.CincinnatiOhio45242-

Find similar trials in Chicago, IL

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By condition
Bladder cancer
By specialty
OncologyUrology
By research site
University of Chicago· Chicago, ILMedical & Surgical Specialists, LLC· Galesburg, ILOncology Hematology Associates of SW Indiana· Evansville, INFort Wayne Oncology & Hematology, Inc· Fort Wayne, INIndiana University Cancer Center· Indianapolis, INQuality Cancer Center (MCGOP)· Indianapolis, IN

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