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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01350817
First received: May 9, 2011
Last updated: October 22, 2013
Last verified: October 2013
  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:


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 2014
Estimated Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01350817

Locations
France
Service de Pneumologie, CHU Angers
Angers, France, 49033
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, France, 74011
Service de Pneumologie
Beauvais, France
Service de Pneumologie; Centre Hospitalier
Beauvais, France, 60 021
Service de Pneumologie
Bordeaux, France
CHU Brest
Brest, France
Service de Pneumologie
Charleville Mezière, France
Service de Pneumologie ; Centre hospitalier
Charleville-Mezieres, France, 08 000
Service de Pneumologie
Créteil, France
Service de Pneumologie; Centre Hospitalier
Draguignan, France, 83300
Service de Pneumologie
Draguignan, France
Service de Pneumologie
Elbeuf, France
Service de Pneumologie
Gap, France
Département de Pathologie Respiratoire du CHU de Limoges
Limoges, France
Service de Pneumologie, Hôpital de la Croix Rousse
Lyon, France
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
Mantes La Jolie, France, 78200
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
Marseille, France, 13274
CH de Meaux
Meaux, France
Service de Pneumologie
Meaux, France
Service de Pneumologie
Mulhouse, France
Service de Pneumologie - Hôpital St Antoine, Paris
Paris, France, 75571
Service de Pneumologie-Allergologie; Centre Hospitalier Général
Perigueux, France, 24019
CHU Reims
Reims, France
Service de Pneumologie, Hôpital Pontchailloux
Rennes, France
Service de Pneumologie; CHG de Roanne
Roanne, France, 42300
Service de Pneumologie; Hôpital Bois Guillaume
Rouen, France, 76233
Clinique Pneumologique; Hôpital Charles Nicolle
Rouen, France, 76031
Hôpital Charles Nicolle, Service de Pneumologie
Rouen, France
Service de Pneumologie, Hôpital Nord
saint Etienne, France
Service de Pneumologie
Villefranche, France
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: October 22, 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 July 23, 2014