Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recruitment status was Active, not recruiting
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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 |
| Study Start Date: | April 1999 |
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 |
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| 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 | |
| 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 Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013