NCT00006116

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 with gemcitabine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

21 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

April 1, 1999

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
3.9 years until next milestone

First Posted

Study publicly available on registry

June 22, 2004

Completed
Last Updated

July 24, 2008

Status Verified

November 1, 2000

First QC Date

August 3, 2000

Last Update Submit

July 23, 2008

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancersquamous cell lung cancerlarge cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung canceradenocarcinoma of the lung

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer Locally advanced Stage IIIB (T4, Nx, M0, or Tx, N3, M0) OR Metastatic disease Stage IV unresectable disease Following cell types eligible: Epidermoid cell Large cell Adenocarcinoma Bidimensionally measurable disease Unresectable recurrence after primary surgery allowed No brain metastasis 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/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1.10 mg/dL Cardiovascular: No uncontrolled cardiac disease Other: No other significant, uncontrolled underlying medical or psychiatric condition No serious active infection Neurologically stable No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics Other: At least 30 days since prior experimental therapy No other concurrent experimental drugs

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

Sponsors & Collaborators

Study Sites (21)

Clinique Sainte Catherine

Avignon, 84082, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Centre Hospitalier Departmental Felix Guyon

Bellepierre, 97400, France

Location

Centre Hospitalier General

Brivé, France

Location

Centre Hospitalier Emile Roux

Eaubonne, 95602, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

C.H. Mans

Le Mans, 72037, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92300, France

Location

Clinique St. Faron

Mareuil-lès-Meaux, 77100, France

Location

Clinique de Docteur Terrioux

Meaux, 77100, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Clinique Du Mont Louis

Paris, 75011, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Claude Gallien

Quincy-sous-Sénart, 91480, France

Location

Groupe Medical Saint Remy

Reims, 51096, France

Location

Clinique les Bleuets

Reims, 51100, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Rene Huguenin

Saint-Cloud, 92210, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Philippe Terrioux, MD

    Clinique de Docteur Terrioux

    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

June 22, 2004

Study Start

April 1, 1999

Last Updated

July 24, 2008

Record last verified: 2000-11

Locations

FR(21)