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Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on August 3, 2000.   Last Updated on May 9, 2009   History of Changes
Sponsor: University of Chicago
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006105
  Purpose

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 Intervention Phase
Bladder Cancer
Drug/Agent Toxicity by Tissue/Organ
Drug: amifostine trihydrate
Drug: cisplatin
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100

Life expectancy:

  • At least 12 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy except contraceptives and replacement steroids

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

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

Other:

  • No other concurrent experimental medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006105

Locations
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
Investigators
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006105     History of Changes
Other Study ID Numbers: CDR0000068116, UCCRC-9193, UCCRC-CTRC-9806, NCI-G00-1831
Study First Received: August 3, 2000
Last Updated: May 9, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adjuvants, Immunologic
Gemcitabine
Cisplatin
Amifostine
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Radiation-Protective Agents
Protective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012