Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

Adenocarcinoma, Bronchiolo-Alveolar Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384826
• Other study ID #: IFCT-0504
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2006
• Last updated: February 12, 2015
• Start date: September 2006
• Est. completion date: February 2014

Study information

• Verified date: February 2015
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma, Bronchiolo-Alveolar

Intervention

Drug:
• erlotinib
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)

Locations

Country	Name	City	State
France	Centre Hospitalier - Pneumologie	Belfort
France	APHP - CHU Avicenne - Oncologie Medicale	Bobigny
France	Centre F. Baclesse	Caen
France	CHU - Pneumologie	Caen
France	CHU Grenoble - pneumologie	Grenoble
France	APHP - Hopital Tenon - Pneumologie	Paris
France	APHP - Saint-Antoine - pneumologie	Paris
France	Institut de Cancérologie de la Loire	Saint-priest En Jarez
France	CHU Lyautey - Pneumologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (2)

Wislez M, Gounant V, Cadranel J. [Bronchioloalveolar carcinoma]. Rev Mal Respir. 2005 Dec;22(6 Pt 2):8S70-5. Review. French. — View Citation

Wislez M, Massiani MA, Milleron B, Souidi A, Carette MF, Antoine M, Cadranel J. Clinical characteristics of pneumonic-type adenocarcinoma of the lung. Chest. 2003 Jun;123(6):1868-77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	16-week Disease Control Rate		4-week	Yes

External Links

•   Official French Intergroup website