Know Cancer

or
forgot password

Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Pneumonic-type Adenocarcinoma (P-ADC), Lung Adenocarcinoma With Bronchiolo-alveolar Feature

Thank you

Trial Information

Phase II of Gefitinib (IRESSA) Administered as First-line Treatment in Patients With Non-resectable Pneumonic-type Adenocarcinoma (P-ADC)


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control rate after 3 months of treatment

Outcome Time Frame:

Month

Safety Issue:

Yes

Principal Investigator

Jacques Cadranel, Pr

Investigator Role:

Principal Investigator

Investigator Affiliation:

IFCT

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IFCT-0401

NCT ID:

NCT00198380

Start Date:

April 2005

Completion Date:

December 2009

Related Keywords:

  • Pneumonic-type Adenocarcinoma (P-ADC)
  • Lung Adenocarcinoma With Bronchiolo-alveolar Feature
  • Adenocarcinoma, Bronchiolo-Alveolar
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Lung Neoplasms

Name

Location