Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006105
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 5, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and amifostine following surgery in treating patients who have locally advanced bladder cancer.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug/Agent Toxicity by Tissue/Organ Drug: amifostine trihydrate Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Phase 2

Detailed Description:


  • Determine the toxicity of adjuvant gemcitabine and cisplatin with amifostine cytoprotection in patients with completely resected locally advanced bladder cancer.
  • Compare recurrence rate in these patients when treated with this regimen to historical control patients who had a cystectomy performed by the same surgeon.

OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, and cisplatin IV over 60 minutes and amifostine IV over 15 minutes on day 1. Treatment continues every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer
Study Start Date : June 2000
Actual Primary Completion Date : November 2004
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
Drug: amifostine trihydrate Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy

Primary Outcome Measures :
  1. Side effects of cisplatin/gemcitabine in combination with amifostine [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Completely resected locally advanced bladder cancer

    • T2-4, N0-2
  • Post radical cystectomy with no gross residual disease
  • No evidence of metastases by CT of chest, abdomen, and pelvis



  • 18 and over

Performance status:

  • Karnofsky 70-100

Life expectancy:

  • At least 12 weeks


  • WBC at least 3,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL (transfusion allowed)


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST and ALT no greater than 3 times ULN


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • No serious concurrent systemic disorders that would preclude study participation
  • No metastatic cancer in past 5 years


Biologic therapy:

  • No concurrent immunotherapy


  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except contraceptives and replacement steroids


  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 4 but no more than 8 weeks since radical cystectomy


  • No other concurrent experimental medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006105

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago

Responsible Party: University of Chicago Identifier: NCT00006105     History of Changes
Other Study ID Numbers: 9193
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 5, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
drug/agent toxicity by tissue/organ

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents