Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

This study is currently recruiting participants.

Verified by Intergroupe Francophone de Cancerologie Thoracique, March 2008

Sponsored by:	Intergroupe Francophone de Cancerologie Thoracique
Information provided by:	Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:	NCT00384826

Purpose

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	Intervention	Phase
Adenocarcinoma, Bronchiolo-Alveolar	Drug: erlotinib Drug: paclitaxel + carboplatine	Phase II

Drug Information available for: Paclitaxel Erlotinib Erlotinib hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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.

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

Primary Outcome Measures:

16-week Disease Control Rate [ Time Frame: 4-week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384826

Contacts

Contact: Jacques Cadranel, Pr	+33 1 56 01 65 31
Contact: Franck Morin	+33 1 56 81 10 45	franck.morin@ifct.fr

Locations

France
CHU - Pneumologie	Recruiting
CAEN, France, 14000
Contact: Gerard Zalcman, Pr
Principal Investigator: Gerard Zalcman, Pr
APHP - Hopital Tenon - Pneumologie	Recruiting
PARIS, France, 75020
Contact: Bernard MILLERON, Dr
Principal Investigator: Bernard Milleron, Dr
Centre F. Baclesse	Recruiting
CAEN, France, 14000
Contact: Radj Gervais, Pr
Principal Investigator: Radj Gervais, Dr
APHP - CHU Avicenne - Oncologie Medicale	Recruiting
Bobigny, France, 93000
Contact: Jean-Francois Morere, Pr
Contact: Jeanne-Marie Brechot, Dr
Principal Investigator: Jean-Francois Morere, Pr
Institut de Cancérologie de la Loire	Recruiting
SAINT-PRIEST EN JAREZ, France, 42271
Contact: Pierre Fournel, Dr
Principal Investigator: Pierre Fournel, Dr
Centre Hospitalier - Pneumologie	Recruiting
Belfort, France, 90016
Contact: Jean-Luc Breton, Dr +33 3 84 98 51 18
CHU Grenoble - pneumologie	Recruiting
Grenoble, France, 38000
Contact: Denis Moro-Sibilot, Pr
Principal Investigator: Denis Moro-Sibilot, Pr
CHU Lyautey - Pneumologie	Recruiting
Strasbourg, France, 63000
Contact: Elisabeth Quoix, Pr
Principal Investigator: Elisabeth Quoix, Pr
APHP - Saint-Antoine - pneumologie	Recruiting
PARIS, France, 75012
Contact: Bernard LEBEAU, Pr

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

Investigators

Principal Investigator:

Jacques Cadranel

APHP Hopital Tenon (Pneumologie) - Paris - France

More Information

Official French Intergroup website This link exits the ClinicalTrials.gov site

Publications:

Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma] Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. Review. French.

Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77.

Responsible Party:	IFCT ( Intergroupe Francophone de Cancerologie Thoracique )
Study ID Numbers:	IFCT-0504
Study First Received:	October 5, 2006
Last Updated:	March 27, 2008
ClinicalTrials.gov Identifier:	NCT00384826
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:

Adenocarcinoma, Bronchiolo-Alveolar

Study placed in the following topic categories:

Erlotinib
Paclitaxel
Adenocarcinoma, Bronchiolo-Alveolar

Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Enzyme Inhibitors
Antimitotic Agents
Protein Kinase Inhibitors
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009