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

First Line Treatment of Stage IIIb/IV Non Small Cell (NSC) Lung Cancer With a Bimonthly Administration of a Combination of Cisplatin-Gemcitabine

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: cisplatin; Drug: gemcitabine hydrochloride

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
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group
• Investigators: Study Chair: Philippe Terrioux, MD, Clinique de Docteur Terrioux

Study record dates

Study Major Dates

• Study Start: April 1, 1999

Study Registration Dates

• First Submitted: August 3, 2000
• First Submitted That Met QC Criteria: June 21, 2004
• First Posted (Estimate): June 22, 2004

Study Record Updates

• Last Update Posted (Estimate): July 24, 2008
• Last Update Submitted That Met QC Criteria: July 23, 2008
• Last Verified: November 1, 2000

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; squamous cell lung cancer; large cell lung cancer; adenocarcinoma of the lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine; Cisplatin
• Other Study ID Numbers: CDR0000068129; FRE-GERCOR-B98-1; EU-20026