Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR
Conditions
Stage IV Lung Cancer
Conditions: official terms
Lung Neoplasms
Conditions: Keywords
lung cancer, women
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Gefitinib Type: Drug
Name: Fulvestrant Type: Drug
Name: Erlotinib Type: Drug
Overall Status
Recruiting
Summary
Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better

Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above.

- One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy.

- Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis.

- Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models.

EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations.

The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically confirmed predominant non-squamous, non-small cell lung cancer

- The presence of analysable tissue for the research of EGFR activating mutation. Analysis must be performed in INCa-labelled laboratories or platforms according to a validated technique

- Not suitable for radiation, inoperable stage III or stage IV

- Patients with an EGFR mutation must never have taken chemotherapy or must be in progression after only one previous line of chemotherapy (including maintenance). Patients without an EGFR mutation must have received one or two lines of chemotherapy beforehand. Maintenance chemotherapy is not considered to be a treatment line. Adjuvant chemotherapy is not considered to be a first line of treatment if it dates back to over a year

- Female

- Menopausal: older than 60 years of age or history of ovariectomy or younger than 60 years old with amenorrhoea for more than 12 months or an FSH rate that corresponds to a post-menopausal rate (according to the laboratory)

Exclusion Criteria:

- History of cancer except for skin cancer or cancer dating from over five years ago and considered to be cured

- Known or suspected Cerebral metastases or spinal cord compression unless they are asymptomatic without treatment or stable after being treated by surgery and/or radiation therapy. Corticosteroid treatments for symptoms must have discontinued for more than four weeks

- Pregnancy and breast-feeding

- Patient taking hormone replacement therapy for menopause that has not been stopped two weeks before the start of the trial treatment

- A change in bone marrow, kidney and liver functions inconsistent with treatment
Locations
Annemasse - CH
Ambilly, France
Status: Recruiting
Contact: Patrick CHATELLAIN, Dr
Clinique de l'Europe
Amiens, France
Status: Recruiting
Contact: Olivier CARRE - contact@ifct.fr
Angers - CHU
Angers, France
Status: Recruiting
Contact: Nathalie Baize, Dr
CH de la Côte Basque
Bayonne, France
Status: Recruiting
Contact: Sophie SCHNEIDER - contact@ifct.fr
CHU Besancon - Pneumologie
Besancon, France
Status: Recruiting
Contact: Virginie Westeel, Pr - contact@ifct.fr
Bobigny - Hôpital Avicenne
Bobigny, France
Status: Recruiting
Contact: Jean-Francois MORERE, Pr
Hôpital Ambroise Paré - Pneumologie
Boulogne, France
Status: Recruiting
Contact: Sylvie LABRUNE
HCL Hôpital Louis Pradel
Bron, France
Status: Recruiting
Contact: Bénédicte MASTROIANNI
Béziers - CH
Béziers, France
Status: Recruiting
Contact: Frédéric GOUTORBE, Dr
Caen - Centre François Baclesse
Caen, France
Status: Recruiting
Contact: Pascal DO, Dr - contact@ifct.fr
Caen - CHU Côte de Nacre
Caen, France
Status: Recruiting
Contact: Gerard ZALCMAN, Pr
Cahors - CH
Cahors, France
Status: Recruiting
Contact: Patricia Barré, Dr
Chambéry - CH
Chambéry, France
Status: Recruiting
Contact: Violaine FRAPPAT, MD
Centre Hospitalier
Chauny, France
Status: Recruiting
Contact: Patrick DUMONT, MD
Hôpital de Cholet - Pneumologie
Cholet, France
Status: Recruiting
Contact: Philippe MASSON - contact@ifct.fr
Clamart - Hôpital Percy
Clamart, France
Status: Recruiting
Contact: Fabien VAYLET, Dr - contact@ifct.fr
CHU
Clermont-Ferrand, France
Status: Recruiting
Contact: Gaelle JEANNIN, MD
CH
Colmar, France
Status: Recruiting
Contact: Lionel MOREAU
Clinique des Cèdres
Cornebarrieu, France
Status: Recruiting
Contact: Pierre MOURLANETTE - contact@ifct.fr
Créteil - CHI
Créteil, France
Status: Recruiting
Contact: Isabelle Monnet, Dr - contact@ifct.fr
CH de Dax
Dax, France
Status: Recruiting
Contact: Jérôme DAUBA
Dijon - CAC
Dijon, France
Status: Recruiting
Contact: Laure Favier, MD
Grenoble - CHU
Grenoble, France
Status: Recruiting
Contact: Anne-Claire TOFFART, Dr
Chartres - CH
Le Coudray, France
Status: Recruiting
Contact: Marc Zaegel, Dr
Centre Hospitalier - Pneumologie
Le Mans, France
Status: Recruiting
Contact: Olivier Molinier, Dr
CHU (Hôpital Calmette) - Pneumologie
Lille, France
Status: Recruiting
Contact: Alexis Cortot, Dr
CH
Longjumeau, France
Status: Recruiting
Contact: Gérard OLIVIERO
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
Marseille, France
Status: Recruiting
Contact: Fabrice BARLESI
Institut Paoli Calmette
Marseille, France
Status: Recruiting
Contact: Anne MADROSZYK, Dr
Polyclinique du Val de Sambre
Maubeuge, France
Status: Recruiting
Contact: Marc DEROLLEZ - contact@ifct.fr
Mont de Marsan - CH
Mont de Marsan, France
Status: Recruiting
Contact: Jérome Dauba, Dr
Mulhouse - CH
Mulhouse, France
Status: Recruiting
Contact: Didier DEBIEUVRE, Dr
CHU Nancy
Nancy, France
Status: Recruiting
Contact: Christelle CLEMENT DUCHENE - contact@ifct.fr
Nantes - Centre René Gauducheau
Nantes, France
Status: Recruiting
Contact: Sandrine HIRET, Dr
Nevers - CH
Nevers, France
Status: Recruiting
Contact: Dominique Herman, Dr
Centre Antoine Lacassagne
Nice, France
Status: Recruiting
Contact: Josiane OTTO, MD - contact@ifct.fr
HIA Val-de-Grâce
Paris, France
Status: Recruiting
Contact: Sylvestre LE MOULEC
Hopital Tenon - Pneumologie
Paris, France
Status: Recruiting
Contact: Jacques Cadranel, Pr - +33.1.56.01.65.31 - jacques.cadranel@tnn.ap-hop-paris.fr
Hôpital Bichat - Claude - Bernard
Paris, France
Status: Recruiting
Contact: Jean-Michel RODIER - contact@ifct.fr
Hôpital Européen Georges Pompidou
Paris, France
Status: Recruiting
Contact: Elisabeth FABRE-GUILLEVIN, Dr
Hôpital Saint-Joseph
Paris, France
Status: Recruiting
Contact: Jean TREDANIEL, MD, PhD
Paris - Curie
Paris, France
Status: Recruiting
Contact: Catherine DANIEL, Dr
Pau - CH
Pau, France
Status: Recruiting
Contact: Aldo RENAULT, Dr - contact@ifct.fr
Perpignan - Ch
Perpignan, France
Status: Recruiting
Contact: Christina ROSCA-PAL, Dr - contact@ifct.fr
HCL - Lyon Sud (Pneumologie)
Pierre Bénite, France
Status: Recruiting
Contact: Pierre-Jean Souquet, Dr
Centre Hospitalier
Rambouillet, France
Status: Recruiting
Contact: Hélène LAIZE, MD
CHU de Reims
Reims, France
Status: Recruiting
Contact: Lidia PETIT
Institut Jean Godinot
Reims, France
Status: Recruiting
Contact: Alain PREVOST, MD
Rouen - CHU
Rouen, France
Status: Recruiting
Contact: Suzanna BOTA, Dr
Saint Quentin - CH
Saint Quentin, France
Status: Recruiting
Contact: Charles Dayen, Dr
Strasbourg - NHC
Strasbourg, France
Status: Recruiting
Contact: Bertrand MENNECIER, Dr
Suresnes - Hopital Foch
Suresnes, France
Status: Recruiting
Contact: Séverine FRABOULET-MOREA, Dr
Talent - Clinique mutualiste Bénigne-Joly
Talent, France
Status: Recruiting
Contact: Philippe RAVIER, MD
Centre Hospitalier Intercommunal
Toulon, France
Status: Recruiting
Contact: Clarisse AUDIGIER-VALETTE, Dr
Clinique Pasteur
Toulouse, France
Status: Recruiting
Contact: Christophe RASPAUD - contact@ifct.fr
Toulouse - CHU Larrey
Toulouse, France
Status: Recruiting
Contact: Julien MAZIERES, Pr
Tourcoing - CH
Tourcoing, France
Status: Recruiting
Contact: Emilie PLUQUET, Dr
CHU Tours - Pneumologie
Tours, France
Status: Recruiting
Contact: Eric PICHON
Versailles - CH
Versailles, France
Status: Recruiting
Contact: Cécile DUJON, Dr
CHI de la Haute-Saône - Pneumologie
Vesoul, France
Status: Recruiting
Contact: Jean-Pierre GURY
CH de Villefranche - Pneumologie
Villefranche, France
Status: Recruiting
Contact: Luc ODIER
Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Contact: Benjamin Besse, Dr
Start Date
May 2012
Completion Date
December 2017
Sponsors
Intergroupe Francophone de Cancerologie Thoracique
Source
Intergroupe Francophone de Cancerologie Thoracique
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page