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

Non Small Cell Lung Cancer Clinical Trial

— TARSEQ  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350817
• Other study ID #: I10004
• Status: Completed
• Phase: Phase 2
• First received: May 9, 2011
• Last updated: April 1, 2015
• Start date: May 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: January 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Erlotinib + docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
• Docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks.

Locations

Country	Name	City	State
France	Service de Pneumologie, CHU Angers	Angers
France	Service de pneumologie; Centre Hospitalier d'Annecy	Annecy
France	Service de Pneumologie	Beauvais
France	Service de Pneumologie; Centre Hospitalier	Beauvais
France	Service de Pneumologie	Bordeaux
France	CHU Brest	Brest
France	Service de Pneumologie	Charleville Mezière
France	Service de Pneumologie ; Centre hospitalier	Charleville-Mezieres
France	Service de Pneumologie	Créteil
France	Service de Pneumologie	Draguignan
France	Service de Pneumologie; Centre Hospitalier	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	Département des Maladies Respiratoires ; Hôpital Sainte Marguerite	Marseille
France	CH de Meaux	Meaux
France	Service de Pneumologie	Meaux
France	Service de Pneumologie	Mulhouse
France	Service de Pneumologie - Hôpital St Antoine, Paris	Paris
France	Service de Pneumologie-Allergologie; Centre Hospitalier Général	Perigueux
France	CHU Reims	Reims
France	Service de Pneumologie, Hôpital Pontchailloux	Rennes
France	Service de Pneumologie; CHG de Roanne	Roanne
France	Clinique Pneumologique; Hôpital Charles Nicolle	Rouen
France	Hôpital Charles Nicolle, Service de Pneumologie	Rouen
France	Service de Pneumologie; Hôpital Bois Guillaume	Rouen
France	Service de Pneumologie, Hôpital Nord	saint Etienne
France	Service de Pneumologie	Villefranche

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival at 15 weeks.		at 15 weeks	Yes
Secondary	Free survival at 12 months		12 months	Yes
Secondary	Toxicities and feasibility	To assess toxicities and feasibility in both groups	15 Weeks	Yes