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

The University of Chicago

Status and phase: Completed; Phase 2

Conditions: Bladder Cancer; Drug/Agent Toxicity by Tissue/Organ

Treatments: Drug: cisplatin; Drug: amifostine trihydrate; Drug: gemcitabine hydrochloride; Procedure: adjuvant therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006105

NCI-G00-1831

UCCRC-CTRC-9806

UCCRC-9193

9193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Administration of Cisplatin, Gemcitabine, and Amifostine

Experimental group

Description:

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.

Treatment:

Drug: amifostine trihydrate

Drug: gemcitabine hydrochloride

Drug: cisplatin

Procedure: adjuvant therapy