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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006116
Recruitment Status : Unknown
Verified November 2000 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : June 22, 2004
Last Update Posted : July 24, 2008
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine
Study Start Date : April 1999

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006116

Clinique Sainte Catherine
Avignon, France, 84082
C.H.G. Beauvais
Beauvais, France, 60021
Centre Hospitalier Departmental Felix Guyon
Bellepierre, France, 97400
Centre Hospitalier General
Brive, France
Centre Hospitalier Emile Roux
Eaubonne, France, 95602
Centre Jean Bernard
Le Mans, France, 72000
C.H. Mans
Le Mans, France, 72037
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
Clinique St. Faron
Mareuil Les Meaux, France, 77100
Clinique de Docteur Terrioux
Meaux, France, 77100
Clinique Hartmann
Neuilly sur Seine, France, 92200
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Clinique Du Mont Louis
Paris, France, 75011
Hopital Saint Antoine
Paris, France, 75571
Hopital Tenon
Paris, France, 75970
Hopital Claude Gallien
Quincy Sous Senart, France, 91480
Groupe Medical Saint Remy
Reims, France, 51096
Clinique les Bleuets
Reims, France, 51100
Polyclinique De Courlancy
Reims, France, F-51100
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre du Rouget
Sarcelles, France, 95250
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Chair: Philippe Terrioux, MD Clinique de Docteur Terrioux Identifier: NCT00006116     History of Changes
Other Study ID Numbers: CDR0000068129
First Posted: June 22, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: November 2000

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs