This trial is active, not recruiting.

Condition adenocarcinoma, bronchiolo-alveolar
Treatments erlotinib, paclitaxel + carboplatine
Phase phase 2
Target EGFR
Sponsor Intergroupe Francophone de Cancerologie Thoracique
Start date September 2006
End date July 2012
Trial size 133 participants
Trial identifier NCT00384826, IFCT-0504


To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Erlotinib 150 mg/day (until progression)
paclitaxel + carboplatine
Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)

Primary Outcomes

16-week Disease Control Rate
time frame: 4-week

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - CBA histologically proven (or cytologically with pneumonic presentation) PS < 3 signed and written informed consent Exclusion Criteria: - visible tumoral lesion in bronchial fibroscopy

Additional Information

Official title Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.
Principal investigator Jacques Cadranel
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Intergroupe Francophone de Cancerologie Thoracique.