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Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00384826
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : February 16, 2015
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Brief Summary:
To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

Condition or disease Intervention/treatment Phase
Adenocarcinoma, Bronchiolo-Alveolar Drug: erlotinib Drug: paclitaxel + carboplatine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.
Study Start Date : September 2006
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: erlotinib
Erlotinib 150 mg/day (until progression)
Experimental: 2 Drug: paclitaxel + carboplatine
Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)

Primary Outcome Measures :
  1. 16-week Disease Control Rate [ Time Frame: 4-week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CBA histologically proven (or cytologically with pneumonic presentation) PS < 3 signed and written informed consent

Exclusion Criteria:

  • visible tumoral lesion in bronchial fibroscopy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384826

Centre Hospitalier - Pneumologie
Belfort, France, 90016
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, France, 93000
Centre F. Baclesse
Caen, France, 14000
CHU - Pneumologie
Caen, France, 14000
CHU Grenoble - pneumologie
Grenoble, France, 38000
APHP - Saint-Antoine - pneumologie
Paris, France, 75012
APHP - Hopital Tenon - Pneumologie
Paris, France, 75020
Institut de Cancérologie de la Loire
Saint-priest En Jarez, France, 42271
CHU Lyautey - Pneumologie
Strasbourg, France, 63000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Principal Investigator: Jacques Cadranel APHP Hopital Tenon (Pneumologie) - Paris - France

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00384826     History of Changes
Other Study ID Numbers: IFCT-0504
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Adenocarcinoma, Bronchiolo-Alveolar

Additional relevant MeSH terms:
Adenocarcinoma, Bronchiolo-Alveolar
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib Hydrochloride
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors