NCT00384826

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

7.4 years

First QC Date

October 5, 2006

Last Update Submit

February 12, 2015

Conditions

Adenocarcinoma, Bronchiolo-Alveolar

Keywords

Adenocarcinoma, Bronchiolo-Alveolar

Outcome Measures

Primary Outcomes (1)

  • 16-week Disease Control Rate

    4-week

Study Arms (2)

1

EXPERIMENTAL
Drug: erlotinib

2

EXPERIMENTAL
Drug: paclitaxel + carboplatine

Interventions

erlotinibDRUG

Erlotinib 150 mg/day (until progression)

1
paclitaxel + carboplatineDRUG

Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CBA histologically proven (or cytologically with pneumonic presentation) PS \< 3 signed and written informed consent

You may not qualify if:

  • visible tumoral lesion in bronchial fibroscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier - Pneumologie

Belfort, 90016, France

Location

APHP - CHU Avicenne - Oncologie Medicale

Bobigny, 93000, France

Location

Centre F. Baclesse

Caen, 14000, France

Location

CHU - Pneumologie

Caen, 14000, France

Location

CHU Grenoble - pneumologie

Grenoble, 38000, France

Location

APHP - Saint-Antoine - pneumologie

Paris, 75012, France

Location

APHP - Hopital Tenon - Pneumologie

Paris, 75020, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

CHU Lyautey - Pneumologie

Strasbourg, 63000, France

Location

Related Publications (3)

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

    PMID: 16340839BACKGROUND

  • 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. doi: 10.1378/chest.123.6.1868.

    PMID: 12796162BACKGROUND

  • Cadranel J, Gervais R, Merle P, Moro-Sibilot D, Westeel V, Bigay-Game L, Quoix E, Friard S, Barlesi F, Lethrosne C, Moreau L, Monnet I, Salaun M, Oliviero G, Souquet PJ, Antoine M, Langlais A, Morin F, Wislez M, Zalcman G; Intergroupe Francophone de Cancerologie Thoracique (IFCT). Erlotinib versus carboplatin and paclitaxel in advanced lepidic adenocarcinoma: IFCT-0504. Eur Respir J. 2015 Nov;46(5):1440-50. doi: 10.1183/13993003.02358-2014. Epub 2015 Sep 17.

    PMID: 26381515DERIVED

Related Links

MeSH Terms

Conditions

Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Erlotinib HydrochloridePaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma of LungAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Jacques Cadranel

    APHP Hopital Tenon (Pneumologie) - Paris - France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

September 1, 2006

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

FR(9)