Non Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGErlotinib + docetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
DRUGDocetaxel
docetaxel :75 mg/m² IV day 1 every 3 weeks.
Sponsors
University Hospital, Limoges
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival at 15 Weeks. | at 15 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Survival Rate at 12 Months | 12 months |
| Overall Survival | 12 mois |
| Progression-free Survival | 12 months |
Countries
France
Contacts
STUDY_CHAIRAlain Vergnengre, MD
University Hospital, Limoges
Participant flow
Recruitment details
One hundred fifty six patients were recruited by 33 public hospitals centers between june 2011 and February 2013, of whom 151 were ran-domized.
Pre-assignment details
3 patients did not meet inclusion criteria, 1 patient Refused to participate 1 patient
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 8 |
| Region of Enrollment France | 73 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 74 | 4 / 73 |
| other Total, other adverse events | 52 / 74 | 71 / 73 |
| serious Total, serious adverse events | 66 / 74 | 69 / 73 |
Outcome results
None listed