Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 13, 2005
April 28, 2010
April 2005
December 2008   (final data collection date for primary outcome measure)
Disease control rate after 3 months of treatment [ Time Frame: Month ] [ Designated as safety issue: Yes ]
Disease control rate after 3 months of treatment
Complete list of historical versions of study NCT00198380 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Quality of life
  • Time to progression
  • Survival
  • Prediction disease control by clinical and biological markers
Not Provided
Not Provided
 
Treatment of Lung Adenocarcinoma With Bronchioloalveolar Feature
Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pneumonic-type Adenocarcinoma (P-ADC)
  • Lung Adenocarcinoma With Bronchiolo-alveolar Feature
Drug: Gefitinib
Gefitinib 250 mg/day, until progression or severe toxicity
Experimental: 1
Intervention: Drug: Gefitinib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00198380
IFCT-0401
No
Pr Jacques Cadranel, Intergroupe Francophone de Cancérologie Thoracique
Intergroupe Francophone de Cancerologie Thoracique
AstraZeneca
Principal Investigator: Jacques Cadranel, Pr IFCT
Intergroupe Francophone de Cancerologie Thoracique
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP