NCT00075517

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable 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

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

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
Last Updated

July 24, 2008

Status Verified

July 1, 2007

First QC Date

January 9, 2004

Last Update Submit

July 23, 2008

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IV non-small cell lung canceradenocarcinoma of the lunglarge cell lung cancersquamous cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate

Secondary Outcomes (4)

  • Progression-free survival

  • Overall survival

  • Tolerability

  • Quality of life

Interventions

docetaxelDRUG
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 of 1 of the following histologic subtypes: * Epidermoid carcinoma * Large cell carcinoma * Adenocarcinoma * Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease * Inoperable disease * Measurable disease * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No symptomatic brain metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 2,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than normal * Transaminases no greater than 1.5 times normal * Alkaline phosphatase no greater than 2.5 times normal Renal * Creatinine no greater than 2.3 mg/dL Cardiovascular * No uncontrolled cardiac insufficiency Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study therapy * No uncontrolled infection * No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No grade 3 or 4 brain disorder * No intolerance to polysorbate 80 or cortisones PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy, including taxanes or gemcitabine * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to more than 20% of the bone marrow * No prior radiotherapy for lung cancer * At least 4 weeks since other prior radiotherapy and recovered Surgery * No prior surgery for lung cancer Other * More than 30 days since prior clinical trial participation

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 Avicenne

Bobigny, 93009, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Hopital Perpetuel Secours

Levallois-Perret, 92300, France

Location

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, 77100, France

Location

Clinique de Docteur Terrioux

Meaux, 77100, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Hopital Tenon

Paris, 75970, France

Location

Clinique les Bleuets

Reims, 51100, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Clinique Francois

Saint-Dizier, 52100, France

Location

Hopital Paul Brousse

Villejuif, 94804, France

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

DocetaxelGemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Philippe Terrioux, MD

    Clinique de Docteur Terrioux

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

September 1, 2003

Last Updated

July 24, 2008

Record last verified: 2007-07

Locations

FR(12)