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Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature

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ClinicalTrials.gov Identifier: NCT00198380
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 30, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : April 2005
Primary Completion Date : December 2008
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Gefitinib
Gefitinib 250 mg/day, until progression or severe toxicity


Outcome Measures

Primary Outcome Measures :
  1. Disease control rate after 3 months of treatment [ Time Frame: Month ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 3-month ]
  2. Time to progression [ Time Frame: month ]
  3. Survival [ Time Frame: month ]
  4. Prediction disease control by clinical and biological markers [ Time Frame: month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198380


Locations
France
CHU Besancon - Pneumologie
Besancon, France, 25000
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, France, 93000
Centre F. Baclesse
Caen, France, 14000
CHU - Pneumologie
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
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Adenocarcinoma, Bronchiolo-Alveolar

Additional relevant MeSH terms:
Adenocarcinoma
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action