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Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer (TARSEQ)

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Limoges
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01350817
First received: May 9, 2011
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.

The anticipated time on study treatment is until disease progression. Target sample size is 156.

The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .


Condition Intervention Phase
Non Small Cell Lung Cancer
 Drug: Erlotinib + docetaxel
Drug: Docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • Progression free survival at 15 weeks. [ Time Frame: at 15 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Free survival at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Toxicities and feasibility [ Time Frame: 15 Weeks ] [ Designated as safety issue: Yes ]
    To assess toxicities and feasibility in both groups


Estimated Enrollment: 156
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docetaxel Drug: Docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks.
Experimental: Erlotinib Drug: Erlotinib + docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16

Detailed Description:

In this study, the patient will be randomized in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks.

Assessment during treatment: Physical examination, ECG,: every 3 weeks, laboratory tests: weekly, every 3 weeks pulmonary X-ray .The CT scans:. Measurable targets are assessed by RECIST compared to the beginning of treatment: at 6 weeks (day 42 EVA 2), 12 weeks (D84 EVA 3), 15 weeks (D105 EVA 4: Evaluation of the SSP) and then every 6 weeks until progression.

Quality of life will be assessed Day 42 then every 6 weeks during chemotherapy, Tolerability will be assessed at each visit based on CTC v4.0 criteria.

  Eligibility

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

Inclusion Criteria:

  • Histologically proven NSCLC (
  • Mutational status of EGFR : wild type or unknown
  • Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radiotherapy (with cytologic or histologic documentation of relapse)
  • Presence of at least one measurable target lesion (one dimension) in a non irradiated region (at least 10 mm on spiral computed tomography).
  • Age ≥ 18 years
  • Performance status 0,1,2 exception : age > 74 years only PS 0 or 1
  • Normal hepatic function
  • Normal renal function
  • Normal calcemia
  • Normal haematological function
  • Life expectancy > 12 weeks.
  • Women of child bearing potential must use effective contraception.
  • Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
  • Written informed consent to participate in the study.

Exclusion Criteria:

  • PS > 2, exception : age > 74 years only PS ≥ 2
  • Presence of another cancer
  • Previous treatment with an anti egfr agent or docetaxel
  • QT prolongation (>470 ms)
  • Uncontrolled arterial hypertension.
  • Concurrent radiotherapy, except for palliative bone irradiation.
  • Stroke less than 6 months before study entry.
  • Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
  • Uncontrolled infection.
  • Caval syndrome
  • Other organic disorders preventing inclusion in the trial
  • Malabsorption syndrome
  • Allergy to erlotinib or one of its constituents
  • Allergy to docetaxel or one of its constituents
  • Pregnancy and breast-feeding
  • Surgery less than two months before study entry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350817

Contacts
Contact: Alain Vergnenegre, MD alain.vergnenegre@unilim.fr

Locations
France
Service de Pneumologie, CHU Angers Recruiting
Angers, France, 49033
Contact: Nathalie BAIAZE, MD     33 (0) 2 41 35 58 44     NBaize@chu-angers.fr    
Principal Investigator: Th. Urban, MD            
Sub-Investigator: Y. le Guen, MD            
Service de pneumologie; Centre Hospitalier d'Annecy Recruiting
Annecy, France, 74011
Contact: S. Hominal, MD     33 (0) 4-50-88-33-41     hominal.s@free.fr    
Principal Investigator: H Hominal, MD            
Service de Pneumologie Recruiting
Beauvais, France
Contact: Jacky Crequet, MD     33.3 44 11 22 23     Jacky.crequit@wanadoo.fr    
Sub-Investigator: Jacky crequet, MD            
Service de Pneumologie; Centre Hospitalier Recruiting
Beauvais, France, 60 021
Contact: J. Crequit, MD     33 (0) 3 44 11 22 23     Jacky.crequit@wanadoo.fr    
Principal Investigator: J. Crequit, MD            
Sub-Investigator: E. Bouchaert, MD            
Service de Pneumologie Recruiting
Bordeaux, France
Contact: Jean-Marc VERNEJOUX, MD     33.5 56 55 64 89     jean-marc.vernejoux@chu-bordeaux.fr    
Principal Investigator: jean-marc Vernejoux, MD            
Sub-Investigator: A IZADIFAR, MD            
Sub-Investigator: André TAYTARD, MD            
CHU Brest Recruiting
Brest, France
Contact: G. ROBINET, MD            
Principal Investigator: G ROBINET, MD            
Service de Pneumologie Recruiting
Charleville Mezière, France
Contact: Stephane CHOUABE, MD     33 3 24 58 73 01     stechouabe@voila.fr    
Principal Investigator: Stephane Chouaib, MD            
Service de Pneumologie ; Centre hospitalier Recruiting
Charleville-Mezieres, France, 08 000
Contact: S. Chouaibe, MD     33 (0) 3 24 58 73 01     Schouabe@ch-charleville-mezieres.fr    
Principal Investigator: S. Chouaibe, MD            
Service de Pneumologie Recruiting
Créteil, France
Contact: Isabelle Monnet, MD     33.1 45 17 50 14     Isabelle.Monnet@chicreteil.fr    
Principal Investigator: Isabelle Monnet, MD            
Service de Pneumologie; Centre Hospitalier Recruiting
Draguignan, France, 83300
Contact: H. LE CAER, MD     33 (0)4 94 60 51 12     herve.lecaer@ch-draguignan.fr    
Principal Investigator: H. Lecaer, MD            
Service de Pneumologie Recruiting
Draguignan, France
Contact: Hervé Lecaer, MD     33.4.94 .60.51.12     herve.lecaer@ch-draguignan.fr    
Principal Investigator: Hervé Lecaer, MD            
Service de Pneumologie Recruiting
Elbeuf, France
Contact: Philippe david, MD     33.2 32 96 35 76     davidp@chi.elbeuf-louviers.rss.fr    
Principal Investigator: Philippe David, MD            
Service de Pneumologie Recruiting
Gap, France
Contact: P Thomas, MD     33.4 92 40 61 26     pneumologie@ch-gap.fr    
Principal Investigator: P Thomas, MD            
Département de Pathologie Respiratoire du CHU de Limoges Recruiting
Limoges, France
Principal Investigator: Aain VERGNENEGRE, MD            
Service de Pneumologie, Hôpital de la Croix Rousse Recruiting
Lyon, France
Contact: Maurice Perol, MD     33 4 72 07 17 28     maurice.perol@chu-lyon.fr    
Sub-Investigator: E Biron, MD            
Principal Investigator: Maurice Perol, MD            
Sub-Investigator: Jean-claude GUERIN, MD            
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay Recruiting
Mantes La Jolie, France, 78200
Contact: JB. Auliac, MD     33 (0)1 34 97 40 70     j-b.auliac@ch-mantes-la-jolie.rss.fr    
Principal Investigator: JB. Auliac, MD            
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite Recruiting
Marseille, France, 13274
Contact: C. C GIMENEZ, MD     33( 0)4 91 74 47 36     celine.gimenez@mail.ap-hm.fr    
Sub-Investigator: C. Gimenez, MD            
Sub-Investigator: F. Barlesi, MD            
CH de Meaux Recruiting
Meaux, France
Principal Investigator: Chrystèle LOCHER, MD            
Service de Pneumologie Recruiting
Meaux, France
Contact: M Grivaux, MD     331 64 35 38 56     m-grivaux@ch-meaux.fr    
Principal Investigator: M Grivaux, MD            
Service de Pneumologie Recruiting
Mulhouse, France
Contact: P Bombaron, MD     33.3.89.64.73.96     bombaronp@ch-mulhouse.fr    
Principal Investigator: p Bombaron, MD            
Service de Pneumologie - Hôpital St Antoine, Paris Recruiting
Paris, France, 75571
Contact: Ch. Chouaid, MD     33 (0)1 49 28 25 12     christos.chouaid@sat.ap-hop-paris.fr    
Principal Investigator: Ch. Chouaid, MD            
Service de Pneumologie-Allergologie; Centre Hospitalier Général Recruiting
Perigueux, France, 24019
Contact: JY. Delhoume, MD     33(0) 5 53 07 71 36     jy.delhoume@ch-perigueux.fr    
Principal Investigator: JY Delhoume, MD            
CHU Reims Recruiting
Reims, France
Contact: F LEBARGY, MD            
Principal Investigator: F LEBARGY, MD            
Service de Pneumologie, Hôpital Pontchailloux Recruiting
Rennes, France
Contact: Hervé Lena, MD     33.2 99 28 24 81     herve.lena@chu-rennes.fr    
Principal Investigator: Hervé Lena, MD            
Sub-Investigator: Chantal Belleguic            
Sub-Investigator: Philippe Delaval, MD            
Service de Pneumologie; CHG de Roanne Recruiting
Roanne, France, 42300
Contact: V. Grangeon, MD     33 (0)4 77 44 30 64     valérie.grangeon@ch-roanne.fr    
Principal Investigator: V. Grangeon, MD            
Service de Pneumologie; Hôpital Bois Guillaume Recruiting
Rouen, France, 76233
Contact: D. Paillotin, MD     33 (0) 2 32 88 90 83     dominique.paillotin@chu-rouen.fr    
Principal Investigator: D. Paillotin, MD            
Sub-Investigator: J.F. MUIR, MD            
Clinique Pneumologique; Hôpital Charles Nicolle Recruiting
Rouen, France, 76031
Contact: L. Thiberville, MD     33 (0) 2 32 88 82 47     luc.thiberville@chu-rouen.fr    
Principal Investigator: L. Thiberville, MD            
Sub-Investigator: S. Bota, MD            
Sub-Investigator: G. Nouvet, MD            
Hôpital Charles Nicolle, Service de Pneumologie Recruiting
Rouen, France
Contact: Suzanne Bota, MD     33.2 32 88 82 47     suzane.bota@chu-rouen.fr    
Principal Investigator: Suzanne Bota, MD            
Service de Pneumologie, Hôpital Nord Recruiting
saint Etienne, France
Contact: P FOURNEL, MD     33 4 77 82 83 14     pierre.fournel@chu-st-etienne.fr    
Principal Investigator: Pierre Fournel, MD            
Sub-Investigator: Isabelle Court-Fortune, MD            
Service de Pneumologie Recruiting
Villefranche, France
Contact: L falchero, MD     33.4 74 09 27 23     lfalchero@ch-villefranche.fr    
Principal Investigator: L Falchero, MD            
Sponsors and Collaborators
University Hospital, Limoges
Hoffmann-La Roche
Investigators
Study Chair: Alain Vergnengre, MD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01350817     History of Changes
Other Study ID Numbers: I10004
Study First Received: May 9, 2011
Last Updated: February 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Docetaxel
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013