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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

amifostine trihydrate

cisplatin

gemcitabine hydrochloride

adjuvant therapy

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, drug/agent toxicity by tissue/organ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Chicago Cancer Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of Cisplatin, Gemcitabine, and Amifostine

Arm 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.

Outcomes

Primary Outcome Measures

Side effects of cisplatin/gemcitabine in combination with amifostine

Secondary Outcome Measures

Full Information

NCT ID

NCT00006105

First Posted

August 3, 2000

Last Updated

September 4, 2013

Sponsor

University of Chicago

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00006105

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

June 2000 (undefined)

Primary Completion Date

November 2004 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer, Drug/Agent Toxicity by Tissue/Organ

Keywords

stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, drug/agent toxicity by tissue/organ

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Administration of Cisplatin, Gemcitabine, and Amifostine

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

amifostine trihydrate

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Type

Procedure

Intervention Name(s)

adjuvant therapy

Primary Outcome Measure Information:

Title

Side effects of cisplatin/gemcitabine in combination with amifostine

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter M. Stadler, MD, FACP

Organizational Affiliation

University of Chicago

Official's Role

Study Chair

Facility Information:

Facility Name

University of Chicago Cancer Research Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1470

Country

United States

Bladder Cancer, Drug/Agent Toxicity by Tissue/Organ

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial