Text Size

Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:
NCT00384826
First received: October 5, 2006
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma, Bronchiolo-Alveolar
 Drug: erlotinib
Drug: paclitaxel + carboplatine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:
  • 16-week Disease Control Rate [ Time Frame: 4-week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: September 2006
Estimated Study Completion Date: July 2013
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: erlotinib
Erlotinib 150 mg/day (until progression)
Experimental: 2 Drug: paclitaxel + carboplatine
Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00384826

Locations
France
Centre Hospitalier - Pneumologie
Belfort, France, 90016
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
APHP - Hopital Tenon - Pneumologie
Paris, France, 75020
APHP - Saint-Antoine - pneumologie
Paris, France, 75012
Institut de Cancérologie de la Loire
Saint-priest En Jarez, France, 42271
CHU Lyautey - Pneumologie
Strasbourg, France, 63000
Sponsors and Collaborators
Intergroupe Francophone de Cancerologie Thoracique
Investigators
Principal Investigator: Jacques Cadranel APHP Hopital Tenon (Pneumologie) - Paris - France
  More Information

Additional Information:
Official French Intergroup website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT00384826     History of Changes
Other Study ID Numbers: IFCT-0504
Study First Received: October 5, 2006
Last Updated: September 11, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Adenocarcinoma, Bronchiolo-Alveolar
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Paclitaxel
Erlotinib
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013