Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

NCT00198380 | Completed Phase 2

• 1 other identifier: IFCT-0401
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 11

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.

Conditions

Pneumonic-type Adenocarcinoma (P-ADC); Lung Adenocarcinoma With Bronchiolo-alveolar Feature

Keywords

Adenocarcinoma, Bronchiolo-Alveolar

Outcome Measures

Primary Outcomes (1)

• Disease control rate after 3 months of treatment

  Month

Secondary Outcomes (4)

• Quality of life

  3-month

• Time to progression

  month

• Survival

  month

• Prediction disease control by clinical and biological markers

  month

Study Arms (1)

1

EXPERIMENTAL

Drug: Gefitinib

Interventions

Gefitinib DRUG

Gefitinib 250 mg/day, until progression or severe toxicity

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Abnormal initial fibroscopy

Sponsors & Collaborators

• Intergroupe Francophone de Cancerologie Thoracique: lead
• AstraZeneca: collaborator

Study Sites (11)

CHU Besancon - Pneumologie

Besançon, 25000, France

Location

APHP - CHU Avicenne - Oncologie Medicale

Bobigny, 93000, France

Location

Centre F. Baclesse

Caen, 14000, France

Location

CHU - Pneumologie

Caen, 14000, France

Location

CHU Grenoble - pneumologie

Grenoble, 38000, France

Location

HCL - Croix-Rousse

Lyon, 69000, France

Location

APHP - Saint-Antoine - pneumologie

Paris, 75012, France

Location

Hopital Tenon - Pneumologie

Paris, 75020, France

Location

HCL - Lyon Sud (Pneumologie)

Pierre-Bénite, 69495, France

Location

CHU Saint-Etienne Pneumologie

Saint-Etienne, 42000, France

Location

CHU Lyautey - Pneumologie

Strasbourg, 63000, France

Location

Related Publications (5)

• 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.

  PMID: 18235410 BACKGROUND

• 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.

  PMID: 12796162 BACKGROUND

• 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.

  PMID: 17409882 BACKGROUND

• 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.

  PMID: 19574932 RESULT

• 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.

  PMID: 19581016 RESULT

Related Links

• Official website

MeSH Terms

Conditions

Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jacques Cadranel, Pr

  Intergroupe Francophone de Cancerologie Thoracique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

FR (11)