NCT00003133

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy following surgery in treating patients with advanced bladder cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

April 30, 2004

Completed
Last Updated

June 28, 2013

Status Verified

June 1, 2013

Enrollment Period

5.3 years

First QC Date

November 1, 1999

Last Update Submit

June 26, 2013

Conditions

Bladder CancerTransitional Cell Cancer of the Renal Pelvis and Ureter

Keywords

stage III bladder cancerstage IV bladder cancertransitional cell carcinoma of the bladdermetastatic transitional cell cancer of the renal pelvis and ureterregional transitional cell cancer of the renal pelvis and ureter

Interventions

filgrastimBIOLOGICAL
cisplatinDRUG
doxorubicin hydrochlorideDRUG
gemcitabine hydrochlorideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Pathologically proven complete resection of locally advanced transitional cell carcinoma of the urothelium with negative margins Disease extends beyond the bladder, the ureter, or into the regional lymph nodes Stages eligible for patients with bladder cancer: Tany, N+, M0 T3b, N0, M0 T4a, N0, M0 Stages eligible for patients with urothelial cancer of the renal pelvis or ureter: Tany, N+, M0 T3, N0, M0 T4, N0, M0 Local control of primary urothelial tumor obtained by: Cystoprostatectomy plus pelvic lymph node dissection for bladder cancer in males Cystectomy/TAH/BSO and pelvic lymph node dissection for bladder cancer in females Nephroureterectomy for disease involving the renal pelvis or ureter PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% ECOG 0-1 Life expectancy: Not specified Hematopoietic: Platelet count at least 150,000/mm3 Granulocyte count at least 1500/mm3 Hepatic: Bilirubin less than 1.5 times normal SGOT and alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 60 mL/ min Cardiovascular: LVEF at least 50% No New York Heart Association class II or IV heart disease No serious cardiac arrhythmias, including first, second, or third degree heart block Other: No concurrent second malignancy except nonmelanomatous skin cancer or curatively treated in situ carcinoma of the cervix No uncontrolled infection Fertile patients must use barrier method contraception before, during, and for 6 months after therapy and are encouraged to continue barrier method contraception for 2 years or longer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior irradiation of the bladder Surgery: See Disease Characteristics Definitive surgery performed within 10 weeks of study treatment start

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

FilgrastimCisplatinDoxorubicinGemcitabinePaclitaxel

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Dean F. Bajorin, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 30, 2004

Study Start

September 1, 1997

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

June 28, 2013

Record last verified: 2013-06

Locations

US(1)