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Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer, Drug/Agent Toxicity by Tissue/Organ

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Trial Information

Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Side effects of cisplatin/gemcitabine in combination with amifostine

Outcome Time Frame:

4 months

Safety Issue:

Yes

Principal Investigator

Walter M. Stadler, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

9193

NCT ID:

NCT00006105

Start Date:

June 2000

Completion Date:

September 2006

Related Keywords:

  • Bladder Cancer
  • Drug/Agent Toxicity by Tissue/Organ
  • stage II bladder cancer
  • stage III bladder cancer
  • stage IV bladder cancer
  • drug/agent toxicity by tissue/organ
  • Urinary Bladder Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637