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Sponsored by: |
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075517 |
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer |
Study Start Date: | September 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive docetaxel IV over 1 hour and gemcitabine IV over 2 hours on day 1. Treatment repeats every 15 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, after courses 6 and 12, and then every 3 months thereafter.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
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 of 1 of the following histologic subtypes:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
France | |
American Hospital of Paris | |
Neuilly Sur Seine, France, F-92202 | |
Centre de Radiotherapie et Oncologie Saint-Faron | |
Mareuil Les Meaux, France, 77100 | |
Centre Jean Bernard | |
Le Mans, France, 72000 | |
Centre Rene Huguenin | |
Saint Cloud, France, 92211 | |
Clinique de Docteur Terrioux | |
Meaux, France, 77100 | |
Clinique Francois | |
Saint-Dizier, France, 52100 | |
Polyclinique De Courlancy | |
Reims, France, F-51100 | |
Hopital Avicenne | |
Bobigny, France, 93009 | |
Hopital Paul Brousse | |
Villejuif, France, 94804 | |
Hopital Perpetuel Secours | |
Levallois-Perret, France, 92300 | |
Hopital Tenon | |
Paris, France, 75970 | |
Clinique les Bleuets | |
Reims, France, 51100 |
Investigator: | Philippe Terrioux, MD | Clinique de Docteur Terrioux |
Study ID Numbers: | CDR0000346806, FRE-GERCOR-DOCEGEM-B00-2, EU-20331 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075517 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung large cell lung cancer squamous cell lung cancer |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Immunologic Factors Immunosuppressive Agents Antiviral Agents Carcinoma Docetaxel Radiation-Sensitizing Agents |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Docetaxel Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses |
Gemcitabine Respiratory Tract Neoplasms Neoplasms by Histologic Type Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Carcinoma Neoplasms Radiation-Sensitizing Agents Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |