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Sponsors and Collaborators: |
Intergroupe Francophone de Cancerologie Thoracique AstraZeneca Sanofi-Aventis |
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Information provided by: | Intergroupe Francophone de Cancerologie Thoracique |
ClinicalTrials.gov Identifier: | NCT00198393 |
Patients presenting a deterioration of the general state (performance status [PS] 2-3), constitute a population which needs an adapted treatment. An analysis was made of the evolution of PS 2 patients included in the Eastern Cooperative Oncology Group (ECOG) 1594 trial which evaluated associations of new cytotoxic agents (gemcitabine, paclitaxel, docetaxel) with cisplatin. During this trial, the inclusion of these patients stopped due to the occurrence of toxicities more frequent than in the other populations (PS 0-1). At the end of this study, with the analysis of total toxicity, this one was not higher than that noted in the groups of PS 0 and 1 patients. In the population of PS 2 patients, 5 deaths had been noted, but the analysis showed that only 2 were due to the treatment. It was noted that the lower survival compared to the others was related to the disease and not to the treatment.
These patients are often symptomatic and need palliative treatment. The benefit of chemotherapy should not be denied. They should profit from a monochemotherapy with the new cytotoxic agents, without associated platinum salt.
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Gefitinib Drug: gemcitabine Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV |
Enrollment: | 126 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Gefitinib
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Drug: Gefitinib
250 mg/day, until progression
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B: Experimental
Gemcitabine
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Drug: gemcitabine
1250 mg/m² D1 and D8 (D1=D28, until progression)
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C: Experimental
Docetaxel
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Drug: Docetaxel
75 mg/m² D1 (D1=D22, until progression)
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Arm A Iressa 250 mg daily PROG/TOX --> Taxotere 75 mg/m² d1 (d1=d22)
Arm B Gemzar 1250 mg/m² d1 & d8 (d1=d22) PROG/TOX --> Iressa 250 mg daily
Arm C Taxotere 75 mg/m² d1 (d1=d22) PROG/TOX --> Iressa 250 mg daily
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
France | |
CHU Avicenne - Oncologie | |
Bobigny, France, 93000 | |
CHU Grenoble - pneumologie | |
Grenoble, France, 38000 |
Principal Investigator: | Jean-Francois Morere, Pr | IFCT |
Principal Investigator: | Denis Moro-Sibilot, Pr | IFCT |
Responsible Party: | Intergroupe Francophone de Cancérologie Thoracique ( Pr Jean-François Morère ) |
Study ID Numbers: | IFCT-0301 |
Study First Received: | September 13, 2005 |
Last Updated: | March 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00198393 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
stage IIIB/IV NSCLC patients with performance status 2 or 3. |
Thoracic Neoplasms Antimetabolites Immunologic Factors Immunosuppressive Agents Antiviral Agents Carcinoma Docetaxel Radiation-Sensitizing Agents |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Gemcitabine Carcinoma, Non-Small-Cell Lung Gefitinib 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 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 |