Phase II trial of oral vinorelbine in a population of patients with lung cancer with an EGFR mutation, after failure to treatment with TKI in first line.
- Conditions
- Patients with:-Histologically or cytologically confirmed NSCLC (stage IIIB or IV) and-epidermal growth factor receptor (EGFR) positive mutation and-previously treated with tyrosine kinase inhibitor (gefitinib or erlotinib)MedDRA version: 17.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 17.0Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003361-18-PL
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 75
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- Patients > or = 18 years.
- Histologically or cytologically confirmed NSCLC.
- Patients with epidermal growth factor receptor (EGFR) positive mutation.
- Patients progressing or relapsing after treatment with EGFR tyrosine kinase inhibitors but a minimum of 2 weeks must have elapsed prior to start of study treatment.
- Performance status KPS > or = 70% (ECOG/WHO PS 0-1).
- Stage IIIB (with supra-clavicular nodal metastases), stage IV.
- Life expectancy more than 12 weeks.
- Adequate bone marrow, hepatic and renal functions:
Neutrophils > or = 2.0 x 10^9/l, Platelets > or = 100 x 10^9/l, Haemoglobin > or = 10.0 g/dL;
Total bilirubin < or = 1.5 x ULN (Upper Limit of Normal), Transaminases (ALT, AST) < 2.5 x ULN, Alkaline Phosphatases < 5 x ULN;
Calculated creatinine clearance > or = 40 ml/min (Cockcroft and Gault formula).
- Prior therapy:
Chemotherapy: patient must not have had systemic chemotherapy or
immunotherapy (monoclonal antibody);
Radiation therapy: patient is eligible if presence of target lesions outside the irradiated area. A minimum of 2 weeks must have elapsed prior to start of study treatment.
- Presence of at least one measurable lesion (measured in at least one dimension) which has not been previously irradiated (RECIST criteria – version 1.1). Physical examination and ultrasound will not be considered as objective tumour assessments.
- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
- Fertile men must be using an effective method of birth control if their partners are women of childbearing potential throughout the study period and for up to 3 months after the last dose of study treatment.
- The patient must have access to social insurance according to local regulations.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38
Patients with at least one of the following criteria will not be included:
- Known hypersensitivity to the study drug or to drugs with similar chemical structures.
- Participation in another clinical trial with any experimental drug (except approved EGFR-TKIs) within the 30 days before registration and/or during the study.
- Any important factor likely to modify drug absorption (e.g. surgery of the gastrointestinal tract, significant malabsorption syndrome or disease affecting the gastrointestinal tract function).
- Previous radiotherapy in the only site used to assess response.
- Clinically relevant or unstable systemic disease making implementation of the protocol difficult.
- Active brain metastases except for the followings:
Asymptomatic brain metastases
incidentally found during screening process which does not require local treatment in the opinion of the investigator (2nd cohort, postamendment
PA04).
Asymptomatic brain metastases for which local treatment has been given: at least 1 week off corticosteroids and/or anticonvulsants treatment before study
registration (2nd cohort, postamendment PA04).
- Meningeal carcinomatosis.
- Symptomatic neuropathy (sensory) > or = grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 2).
- Weight loss > 10% within the previous 3 months.
- Long term oxygen therapy.
- Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment).
- Women if pregnant or lactating or with positive pregnancy test at inclusion;
- Women of childbearing potential who did not use or is unwilling or unable to use an acceptable method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment.
- Sexually active fertile men not using effective method of birth control method throughout the study period and for up to 3 months after the last dose of study treatment if his partner is a woman of childbearing potential.
- Other malignancies except adequately treated basal carcinoma of the skin, in-situ cervix carcinoma or any other tumor with a disease free interval > 5 years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method