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

Phase 2
Completed
Conditions
Non Small Cell Lung Cancer
Interventions
Registration Number
NCT01350817
Lead Sponsor
University Hospital, Limoges
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
156
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.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ErlotinibErlotinib + docetaxel-
DocetaxelDocetaxel-
Primary Outcome Measures
NameTimeMethod
Progression free survival at 15 weeks.at 15 weeks
Secondary Outcome Measures
NameTimeMethod
Free survival at 12 months12 months
Toxicities and feasibility15 Weeks

To assess toxicities and feasibility in both groups

Trial Locations

Locations (20)

Service de pneumologie; Centre Hospitalier d'Annecy

🇫🇷

Annecy, France

Service de Pneumologie; Centre Hospitalier

🇫🇷

Draguignan, France

Service de Pneumologie; CHG de Roanne

🇫🇷

Roanne, France

Service de Pneumologie, Hôpital de la Croix Rousse

🇫🇷

Lyon, France

Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay

🇫🇷

Mantes La Jolie, France

CH de Meaux

🇫🇷

Meaux, France

Département des Maladies Respiratoires ; Hôpital Sainte Marguerite

🇫🇷

Marseille, France

CHU Reims

🇫🇷

Reims, France

Service de Pneumologie, Hôpital Pontchailloux

🇫🇷

Rennes, France

Service de Pneumologie; Hôpital Bois Guillaume

🇫🇷

Rouen, France

Service de Pneumologie-Allergologie; Centre Hospitalier Général

🇫🇷

Perigueux, France

Service de Pneumologie - Hôpital St Antoine, Paris

🇫🇷

Paris, France

Clinique Pneumologique; Hôpital Charles Nicolle

🇫🇷

Rouen, France

Service de Pneumologie, Hôpital Nord

🇫🇷

saint Etienne, France

Hôpital Charles Nicolle, Service de Pneumologie

🇫🇷

Rouen, France

Service de Pneumologie, CHU Angers

🇫🇷

Angers, France

Service de Pneumologie ; Centre hospitalier

🇫🇷

Charleville-Mezieres, France

Département de Pathologie Respiratoire du CHU de Limoges

🇫🇷

Limoges, France

Service de Pneumologie

🇫🇷

Villefranche, France

CHU Brest

🇫🇷

Brest, France

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