Clinical trial NCT00198380: Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature
Official title: Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonic-type Adenocarcinoma (P-ADC)
Lung Adenocarcinoma With Bronchiolo-alveolar Feature
Keywords: Adenocarcinoma, Bronchiolo-Alveolar
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2005-09-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Disease control rate after 3 months of treatment
timeFrame: Month
Secondary outcomes:
measure: Quality of life
timeFrame: 3-month
measure: Time to progression
timeFrame: month
measure: Survival
timeFrame: month
measure: Prediction disease control by clinical and biological markers
timeFrame: month
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Bobigny
country: France
facility: APHP - CHU Avicenne - Oncologie Medicale
city: Caen
country: France
facility: Centre F. Baclesse
city: Caen
country: France
facility: CHU - Pneumologie
city: Grenoble
country: France
facility: CHU Grenoble - pneumologie
city: Lyon
country: France
facility: HCL - Croix-Rousse
city: Paris
country: France
facility: APHP - Saint-Antoine - pneumologie
city: Paris
country: France
facility: Hopital Tenon - Pneumologie
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud (Pneumologie)
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne Pneumologie
city: Strasbourg
country: France
facility: CHU Lyautey - Pneumologie
Study officials:
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Jacques Cadranel, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cadranel J, Lavole 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.
citation: 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. doi: 10.1378/chest.123.6.1868.
citation: 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.
citation: 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. doi: 10.1097/JTO.0b013e3181abeb5d.
citation: 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. doi: 10.1016/j.lungcan.2009.05.021. Epub 2009 Jul 5.