NCT00006118

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 combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.

Trial Health

60
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Trial Health Score

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

Geographic Reach
2 countries

12 active sites

Status
unknown

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

July 1, 1999

Completed
1.1 years 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
Last Updated

July 24, 2008

Status Verified

November 1, 2001

First QC Date

August 3, 2000

Last Update Submit

July 23, 2008

Conditions

Bladder Cancer

Keywords

stage III bladder cancerstage IV bladder cancertransitional cell carcinoma of the bladder

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder * Measurable disease by CT or MRI scan * Greater than 10 mm PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 Hepatic: * Not specified Renal: * Creatinine less than 1.36 mg/dL Cardiovascular: * No uncontrolled cardiac disease * No severe cardiac arrhythmias Other: * Not pregnant or nursing * No other prior malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior intravesical immunotherapy for superficial disease allowed * No prior systemic biologic response modifier therapy for advanced disease Chemotherapy: * Prior intravesical chemotherapy for superficial disease allowed * No prior systemic chemotherapy for advanced disease Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy allowed Surgery: * No prior surgery

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

Sponsors & Collaborators

Study Sites (12)

Hopital Drevon

Dijon, 21000, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92300, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Hopital Laennec

Paris, 75007, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Centre Hospitalier Regional Metz Thionville

Thionville, 57126, France

Location

Centre Hospitalier Princesse Grace

Monte Carlo, 98000, Monaco

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

CisplatinGemcitabinePaclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Catherine Maulard-Durdux, MD

    Hopital Tenon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2000

First Posted

January 27, 2003

Study Start

July 1, 1999

Last Updated

July 24, 2008

Record last verified: 2001-11

Locations

MO(1)FR(11)