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	Treatment or Intervention	Phase
stage IV non-small cell lung cancer Squamous Cell Lung Cancer stage IIIB non-small cell lung cancer recurrent non-small cell lung cancer Adenocarcinoma of the Lung Quality of Life large cell lung cancer	Drug: cisplatin  Drug: gemcitabine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   75 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France
      C.H. Mans, Le Mans,  72037,  France
      C.H.G. Beauvais, Beauvais,  60021,  France
      Centre du Rouget, Sarcelles,  95250,  France
      Centre Hospitalier Departmental Felix Guyon, Bellepierre,  97400,  France
      Centre Hospitalier Emile Roux, Eaubonne,  95602,  France
      Centre Hospitalier General, Brive,  France
      Centre Jean Bernard, Le Mans,  72000,  France
      Centre Rene Huguenin, Saint Cloud,  92210,  France
      Clinique de Docteur Terrioux, Meaux,  77100,  France
      Clinique Du Mont Louis, Paris,  75011,  France
      Clinique Hartmann, Neuilly-sur-Seine,  92200,  France
      Clinique les Bleuets, Reims,  51100,  France
      Clinique Sainte Catherine, Avignon,  84082,  France
      Clinique St. Faron, Mareuil-les-Meaux,  77100,  France
      Groupe Medical Saint Remy, Reims,  51096,  France
      Hopital Claude Gallien, Quincy-sous-Senart,  91480,  France
      Hopital Perpetuel Secours, Levallois-Perret,  92300,  France
      Hopital Saint Antoine, Paris,  75571,  France
      Hopital Tenon, Paris,  75970,  France
      Polyclinique De Courlancy, Reims,  F-51100,  France

Study chairs or principal investigators

P. Terrioux,  Study Chair,  GERCOR   

Study ID Numbers:  CDR0000068129; FRE-GERCOR-B98-1; EU-20026
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006116
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08