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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006105
• Other study ID #: 9193
• Secondary ID: UCCRC-9193UCCRC-
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2000
• Last updated: September 4, 2013
• Start date: June 2000
• Est. completion date: September 2006

Study information

• Verified date: September 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2006
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Drug/Agent Toxicity by Tissue/Organ
• Urinary Bladder Neoplasms

Intervention

Drug:
• amifostine trihydrate

• cisplatin

• gemcitabine hydrochloride

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	University of Chicago Cancer Research Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side effects of cisplatin/gemcitabine in combination with amifostine		4 months	Yes