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Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

NCT ID: NCT00006116

Last Updated: 2008-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Brief Summary

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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.

Detailed Description

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OBJECTIVES: I. Determine the efficacy of the combination of cisplatin and gemcitabine in terms of response rate and progression free survival in patients with stage IIIB or IV non-small cell lung cancer. II. Evaluate this treatment regimen in terms of toxicity and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1 hour every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression following 6 courses of therapy receive an additional 6 courses of therapy. Quality of life is assessed prior to each course and then every 3 months. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Conditions

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Lung Cancer

Keywords

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recurrent non-small cell lung cancer squamous cell lung cancer large cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cisplatin

Intervention Type DRUG

gemcitabine hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role lead

Principal Investigators

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Philippe Terrioux, MD

Role: STUDY_CHAIR

Clinique de Docteur Terrioux

Locations

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Clinique Sainte Catherine

Avignon, , France

Site Status

C.H.G. Beauvais

Beauvais, , France

Site Status

Centre Hospitalier Departmental Felix Guyon

Bellepierre, , France

Site Status

Centre Hospitalier General

Brivé, , France

Site Status

Centre Hospitalier Emile Roux

Eaubonne, , France

Site Status

Centre Jean Bernard

Le Mans, , France

Site Status

C.H. Mans

Le Mans, , France

Site Status

Hopital Perpetuel Secours

Levallois-Perret, , France

Site Status

Clinique St. Faron

Mareuil-lès-Meaux, , France

Site Status

Clinique de Docteur Terrioux

Meaux, , France

Site Status

Clinique Hartmann

Neuilly-sur-Seine, , France

Site Status

American Hospital of Paris

Neuilly-sur-Seine, , France

Site Status

Clinique Du Mont Louis

Paris, , France

Site Status

Hopital Saint Antoine

Paris, , France

Site Status

Hopital Tenon

Paris, , France

Site Status

Hopital Claude Gallien

Quincy-sous-Sénart, , France

Site Status

Groupe Medical Saint Remy

Reims, , France

Site Status

Clinique les Bleuets

Reims, , France

Site Status

Polyclinique De Courlancy

Reims, , France

Site Status

Centre Rene Huguenin

Saint-Cloud, , France

Site Status

Centre du Rouget

Sarcelles, , France

Site Status

Countries

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France

Other Identifiers

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FRE-GERCOR-B98-1

Identifier Type: -

Identifier Source: secondary_id

EU-20026

Identifier Type: -

Identifier Source: secondary_id

CDR0000068129

Identifier Type: -

Identifier Source: org_study_id