Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
|ClinicalTrials.gov 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
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|
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)|
|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|
U.S. FDA Resources
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 ClinicalTrials.gov identifier (NCT number): NCT00006116
|Clinique Sainte Catherine|
|Avignon, France, 84082|
|Beauvais, France, 60021|
|Centre Hospitalier Departmental Felix Guyon|
|Bellepierre, France, 97400|
|Centre Hospitalier General|
|Centre Hospitalier Emile Roux|
|Eaubonne, France, 95602|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|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|
|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|
|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|
|Study Chair:||Philippe Terrioux, MD||Clinique de Docteur Terrioux|