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Randomized Phase 2 Study of 3 Therapeutic Modalities in PS 2/3 Patients With NSCLC Stage IIIB/IV
This study is ongoing, but not recruiting participants.
First Received: September 13, 2005   Last Updated: March 31, 2008   History of Changes
Sponsors and Collaborators: Intergroupe Francophone de Cancerologie Thoracique
AstraZeneca
Sanofi-Aventis
Information provided by: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00198393
  Purpose

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
Carcinoma, Non-Small-Cell Lung
Drug: Gefitinib
Drug: gemcitabine
Drug: Docetaxel
Phase II

Drug Information available for: Gemcitabine Docetaxel Gemcitabine hydrochloride
U.S. FDA Resources
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

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: week ] [ Designated as safety issue: Yes ]

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
A: Experimental
Gefitinib
Drug: Gefitinib
250 mg/day, until progression
B: Experimental
Gemcitabine
Drug: gemcitabine
1250 mg/m² D1 and D8 (D1=D28, until progression)
C: Experimental
Docetaxel
Drug: Docetaxel
75 mg/m² D1 (D1=D22, until progression)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage IIIB/IV NSCLC
  • patients with performance status 2 or 3.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00198393

Locations
France
CHU Avicenne - Oncologie
Bobigny, France, 93000
CHU Grenoble - pneumologie
Grenoble, France, 38000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
AstraZeneca
Sanofi-Aventis
Investigators
Principal Investigator: Jean-Francois Morere, Pr IFCT
Principal Investigator: Denis Moro-Sibilot, Pr IFCT
  More Information

Additional Information:
Publications:
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

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
stage IIIB/IV NSCLC
patients with performance status 2 or 3.

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009