NCT00006105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2004

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

September 5, 2013

Status Verified

September 1, 2013

Enrollment Period

4.4 years

First QC Date

August 3, 2000

Last Update Submit

September 4, 2013

Conditions

Bladder CancerDrug/Agent Toxicity by Tissue/Organ

Keywords

stage II bladder cancerstage III bladder cancerstage IV bladder cancerdrug/agent toxicity by tissue/organ

Outcome Measures

Primary Outcomes (1)

  • Side effects of cisplatin/gemcitabine in combination with amifostine

    4 months

Study Arms (1)

Administration of Cisplatin, Gemcitabine, and Amifostine

EXPERIMENTAL

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.

Drug: amifostine trihydrateDrug: cisplatinDrug: gemcitabine hydrochlorideProcedure: adjuvant therapy

Interventions

amifostine trihydrateDRUG
Administration of Cisplatin, Gemcitabine, and Amifostine
cisplatinDRUG
Administration of Cisplatin, Gemcitabine, and Amifostine
gemcitabine hydrochlorideDRUG
Administration of Cisplatin, Gemcitabine, and Amifostine
adjuvant therapyPROCEDURE
Administration of Cisplatin, Gemcitabine, and Amifostine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsDrug-Related Side Effects and Adverse Reactions

Interventions

AmifostineCisplatinGemcitabineChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Walter M. Stadler, MD, FACP

    University of Chicago

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

June 1, 2000

Primary Completion

November 1, 2004

Study Completion

September 1, 2006

Last Updated

September 5, 2013

Record last verified: 2013-09

Locations

US(1)