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Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00198380
First received: September 13, 2005
Last updated: April 28, 2010
Last verified: April 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
APHP - Saint-Antoine - pneumologie
Paris, France, 75012
Hopital Tenon - Pneumologie
Paris, France, 75020
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:
Publications:
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
Lung Neoplasms
Carcinoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014