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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006116
First received: August 3, 2000
Last updated: July 23, 2008
Last verified: November 2000
  Purpose

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 Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006116

Locations
France
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
C.H. Mans
Le Mans, France, 72037
Centre Jean Bernard
Le Mans, France, 72000
Hopital Perpetuel Secours
Levallois-Perret, France, 92300
Clinique St. Faron
Mareuil Les Meaux, France, 77100
Clinique de Docteur Terrioux
Meaux, France, 77100
American Hospital of Paris
Neuilly Sur Seine, France, F-92202
Clinique Hartmann
Neuilly sur Seine, France, 92200
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
Clinique les Bleuets
Reims, France, 51100
Polyclinique De Courlancy
Reims, France, F-51100
Groupe Medical Saint Remy
Reims, France, 51096
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre du Rouget
Sarcelles, France, 95250
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Philippe Terrioux, MD Clinique de Docteur Terrioux
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006116     History of Changes
Other Study ID Numbers: CDR0000068129, FRE-GERCOR-B98-1, EU-20026
Study First Received: August 3, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014