Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature - Full Text View

Purpose

Pneumonic adenocarcinoma (P-ADC) is defined as a primary lung ADC with a radiological pneumonic presentation, usually referred to histologically as ADC with a mixed-invasive and BAC predominant subtype in the 2004 WHO classification. Surgery is the best therapy for resectable tumors since the effectiveness of chemotherapy is disappointing. In the advanced P-ADC diffuse/multifocal types of BAC, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) (gefitinib and erlotinib) have shown promise, with some rapid, dramatic responses, possibly reflecting specific molecular differences from other non-small cell lung carcinomas.

Condition	Intervention	Phase
Pneumonic-type Adenocarcinoma (P-ADC) Lung Adenocarcinoma With Bronchiolo-alveolar Feature	Drug: Gefitinib	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gefitinib

U.S. FDA Resources

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

Primary Outcome Measures:

Disease control rate after 3 months of treatment [ Time Frame: Month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 3-month ] [ Designated as safety issue: Yes ]
Time to progression [ Time Frame: month ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: month ] [ Designated as safety issue: Yes ]
Prediction disease control by clinical and biological markers [ Time Frame: month ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	April 2005
Study Completion Date:	December 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Gefitinib Gefitinib 250 mg/day, until progression or severe toxicity

Detailed Description:

We therefore conducted a French multicentric phase II trial (IFCT 0401) to evaluate activity and tolerance of gefitinib (250 mg/day) administered as first line treatment in patients with non-resectable P-ADC.

Eligibility

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

Criteria

Inclusion Criteria:

Pathologically / cytologically proven ADC-P
Non-resectable disease
3-month expected survival
No prior radiotherapy or chemotherapy
Age >= 18 years old
Performance status < 4 (WHO)
Adequate blood biological parameters

Exclusion Criteria:

Abnormal initial fibroscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198380

Locations

France
CHU Besancon - Pneumologie
Besancon, France, 25000
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, France, 93000
CHU - Pneumologie
Caen, France, 14000
Centre F. Baclesse
Caen, France, 14000
CHU Grenoble - pneumologie
Grenoble, France, 38000
HCL - Croix-Rousse
Lyon, France, 69000
Hopital Tenon - Pneumologie
Paris, France, 75020
APHP - Saint-Antoine - pneumologie
Paris, France, 75012
HCL - Lyon Sud (Pneumologie)
Pierre Bénite, France, 69495
CHU Saint-Etienne Pneumologie
Saint-Etienne, France, 42000
CHU Lyautey - Pneumologie
Strasbourg, France, 63000

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

AstraZeneca

Investigators

Principal Investigator:

Jacques Cadranel, Pr

IFCT

More Information

Additional Information:

Official website This link exits the ClinicalTrials.gov site

Publications:

Cadranel J, Quoix E, Baudrin L, Mourlanette P, Moro-Sibilot D, Morere JF, Souquet PJ, Soria JC, Morin F, Milleron B; IFCT-0401 Trial Group. IFCT-0401 Trial: a phase II study of gefitinib administered as first-line treatment in advanced adenocarcinoma with bronchioloalveolar carcinoma subtype. J Thorac Oncol. 2009 Sep;4(9):1126-35.

Wislez M, Antoine M, Baudrin L, Poulot V, Neuville A, Pradere M, Longchampt E, Isaac-Sibille S, Lebitasy MP, Cadranel J. Non-mucinous and mucinous subtypes of adenocarcinoma with bronchioloalveolar carcinoma features differ by biomarker expression and in the response to gefitinib. Lung Cancer. 2010 May;68(2):185-91. Epub 2009 Jul 5.

Cadranel J, Lavolé A, Gounant V, Wislez M. [Bronchioloalveolar carcinoma and adenocarcinoma with bronchioloalveolar features: a clinico-pathological spectrum] Rev Mal Respir. 2007 Oct;24(8 Pt 2):6S165-70. 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.

Garfield DH, Cadranel JL, Wislez M, Franklin WA, Hirsch FR. The bronchioloalveolar carcinoma and peripheral adenocarcinoma spectrum of diseases. J Thorac Oncol. 2006 May;1(4):344-59. Review. Erratum in: J Thorac Oncol. 2006 Jun;1(5):405.

Responsible Party:	Pr Jacques Cadranel, Intergroupe Francophone de Cancérologie Thoracique
ClinicalTrials.gov Identifier:	NCT00198380 History of Changes
Other Study ID Numbers:	IFCT-0401
Study First Received:	September 13, 2005
Last Updated:	April 28, 2010
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:

Adenocarcinoma, Bronchiolo-Alveolar

Additional relevant MeSH terms:

Adenocarcinoma
Adenocarcinoma, Mucinous
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Respiratory Tract Neoplasms
Thoracic Neoplasms

Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013