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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Walter Stadler, University of Chicago
ClinicalTrials.gov Identifier:
NCT00006105
First received: August 3, 2000
Last updated: January 22, 2013
Last verified: January 2013
History of Changes

August 3, 2000
January 22, 2013
June 2000
November 2004   (final data collection date for primary outcome measure)
Side effects of cisplatin/gemcitabine in combination with amifostine [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00006105 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Gemcitabine, Cisplatin, and Amifostine Following Surgery in Treating Patients With Locally Advanced Bladder Cancer
Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer

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.

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.
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • Drug: amifostine trihydrate
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Procedure: adjuvant therapy
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.
Interventions:
  • Drug: amifostine trihydrate
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Procedure: adjuvant therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
September 2006
November 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006105
9193, UCCRC-9193, UCCRC-CTRC-9806, NCI-G00-1831
No
Walter Stadler, University of Chicago
University of Chicago
National Cancer Institute (NCI)
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
University of Chicago
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP