Clinical trial NCT01350817: Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2011-05-10
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 .

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 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

Primary outcomes:
measure: Progression free survival at 15 weeks.
timeFrame: at 15 weeks
Secondary outcomes:
measure: Free survival at 12 months
timeFrame: 12 months
measure: Toxicities and feasibility
timeFrame: 15 Weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Service de Pneumologie, CHU Angers
city: Annecy
country: France
facility: Service de pneumologie; Centre Hospitalier d'Annecy
city: Beauvais
country: France
facility: Service de Pneumologie; Centre Hospitalier
city: Beauvais
country: France
facility: Service de Pneumologie
city: Bordeaux
country: France
facility: Service de Pneumologie
city: Brest
country: France
facility: CHU Brest
city: Charleville Mezière
country: France
facility: Service de Pneumologie
city: Charleville-Mezieres
country: France
facility: Service de Pneumologie ; Centre hospitalier
city: Créteil
country: France
facility: Service de Pneumologie
city: Draguignan
country: France
facility: Service de Pneumologie; Centre Hospitalier
city: Draguignan
country: France
facility: Service de Pneumologie
city: Elbeuf
country: France
facility: Service de Pneumologie
city: Gap
country: France
facility: Service de Pneumologie
city: Limoges
country: France
facility: Département de Pathologie Respiratoire du CHU de Limoges
city: Lyon
country: France
facility: Service de Pneumologie, Hôpital de la Croix Rousse
city: Mantes La Jolie
country: France
facility: Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
city: Marseille
country: France
facility: Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
city: Meaux
country: France
facility: CH de Meaux
city: Meaux
country: France
facility: Service de Pneumologie
city: Mulhouse
country: France
facility: Service de Pneumologie
city: Paris
country: France
facility: Service de Pneumologie - Hôpital St Antoine, Paris
city: Perigueux
country: France
facility: Service de Pneumologie-Allergologie; Centre Hospitalier Général
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: Service de Pneumologie, Hôpital Pontchailloux
city: Roanne
country: France
facility: Service de Pneumologie; CHG de Roanne
city: Rouen
country: France
facility: Clinique Pneumologique; Hôpital Charles Nicolle
city: Rouen
country: France
facility: Service de Pneumologie; Hôpital Bois Guillaume
city: Rouen
country: France
facility: Hôpital Charles Nicolle, Service de Pneumologie
city: saint Etienne
country: France
facility: Service de Pneumologie, Hôpital Nord
city: Villefranche
country: France
facility: Service de Pneumologie
Study officials:
affiliation: University Hospital, Limoges
name: Alain Vergnengre, MD
role: STUDY_CHAIR
References: