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Sponsors and Collaborators: |
University Hospital, Limoges Groupe Français de Pneumologie Cancérologie (GFPC) |
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Information provided by: | University Hospital, Limoges |
ClinicalTrials.gov Identifier: | NCT00199758 |
The optimal strategy in advanced non small cell lung cancer with stable disease is not well known. There is no published study assessing an early change of chemotherapeutic drugs in these patients.Accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of CDDP-gemcitabine association for patients with stable diseases (SD).
Condition | Intervention | Phase |
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Non Small Cell Lung Carcinoma |
Drug: cisplatin Drug: Gemcitabine Drug: Taxol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Phase II Trial of Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer. |
Estimated Enrollment: | 227 |
Study Start Date: | September 2003 |
Study Completion Date: | June 2007 |
Patients with stage IV NSCLC and measurable disease are included in a randomized phase II trial comparing for patients with stable disease after 2 cycles of a platin (P)-gemcitabine doublet (P d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm A) to a switch to another doublet (arm B) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.Platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). Response criteria are assessed with RECIST classification by the investigator panel.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service de Pathologie Respiratoire | |
Limoges, France | |
Hôpital Charles Nicolle, Service de Pneumologie | |
Rouen, France | |
Département des Maladies Respiratoires | |
Marseille, France | |
Service de Pneumologie, Hôpital Nord | |
saint Etienne, France | |
Service de Pathologie Respiratoire | |
Toulon naval, France | |
Service de Pneumologie | |
Bordeaux, France | |
Service de Pneumologie, Hôpital Pontchailloux | |
Rennes, France | |
Service de Pneumologie - Hôpital St Antoine | |
Paris, France | |
Service de Pneumologie | |
Elbeuf, France | |
Service de Pneumologie | |
Draguignan, France | |
Service de Pneumologie | |
Mantes La Jolie, France | |
Service de Pneumologie, Hôpital de la Croix Rousse | |
Lyon, France | |
Service de Pneumologie | |
Villefranche, France | |
Service de Pneumologie, Hôpital Bois Guillaume | |
Rouen, France | |
Service de Pneumologie | |
Meaux, France | |
Service de Pneumologie | |
Mulhouse, France | |
Service de Pneumologie | |
Créteil, France | |
Service de Pneumologie | |
Beauvais, France | |
Service de Pneumologie-Allergologie | |
Martigues, France | |
Service de Pneumologie | |
Charleville Mezière, France | |
Service de Pneumologie | |
Gap, France |
Principal Investigator: | Alain Vergnengre, MD | University Hospital, Limoges |
Study ID Numbers: | I03022 |
Study First Received: | September 14, 2005 |
Last Updated: | November 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00199758 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Non small cell lung carcinoma Cisplatin Gemcitabine Paclitaxel |
Thoracic Neoplasms Antimetabolites Immunologic Factors Immunosuppressive Agents Antiviral Agents Carcinoma Respiratory Tract Diseases Cisplatin |
Radiation-Sensitizing Agents Lung Neoplasms Paclitaxel Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Cisplatin 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 |