Randomised phase II trial to compare two first line chemotherapy regimen : oral vinorelbine and cisplatin followed by maintenance therapy with single agent oral vinorelbine and gemcitabine and cisplatin followed by maintenance therapy with single agent gemcitabine in Locally Advanced or Metastatic Non-Small-Cell Lung Cancer patients with squamous histological type.
- Conditions
- First line locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) patient with squamous histological type.MedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003531-40-IT
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 110
Patients must satisfy all the following inclusion criteria before they are allowed to participate in the study: - patient must give written informed consent; - Chemo-naive patients superior or equal to 18 years; - Performance status KPS superior or equal to 70% (ECOG/WHO PS 0-1); - Squamous histologically or cytologically (fine needle aspiration is acceptable) proven non-small cell lung cancer; - Stage IIIB (with supra-clavicular nodal metastases), stage IV or relapsing (locally or distant) after a local treatment. Patient not suitable for loco-regional treatment; - Life expectancy more than 12 weeks; - Adequate bone marrow, hepatic and renal functions: • Neutrophils superior or equal to 2.0x109/l, platelets superior or equal to 100x109/l, Haemoglobin superior or equal to 10 g/dl or 6.2 mmol/l. • Total bilirubin inferior or equal to 1.5xULN, Transaminases < 2.5xULN, Alkaline Phosphatases < 5xULN upper Limit of Normal). • Creatinine < ULN (if limit value, creatinine clearance superior or equal to 60 ml/min). - Prior therapy: • Surgery: patients may have had previous surgery for NSCLC; • Chemotherapy: patients must not have had systemic chemotherapy or immunotherapy; • Radiation therapy: patient may have received prior radiotherapy but not on the site used to assess response. A minimum of 4 weeks interval must have elapsed; - Presence of at least one measurable lesion which has not been previously irradiated (RECIST criteria Version 1.1). Measurable lesions (measured in at least one dimension, longest diameter to be recorded) as = 20 mm with conventional techniques or as = 10 mm with CT scan; 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 randomization 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 oral vinorelbine or up to 6 months after the last dose of cisplatin 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 during study period and for up to 3 months following the last dose of oral
vinorelbine or up to 6 months following the last dose of cisplatin or gemcitabine; - 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
Patients with at least one of the following criteria will not be included: - Known hypersensitivity to the study drug(s) or to drugs with similar chemical structures. - Any important factor likely to modify drug absorption, e.g. surgery of gastro-intestinal tract, significant malabsorption syndrome or disease affecting the gastro-intestinal tract function. - Patients with a local relapse, which is liable to be treated by radiation therapy. - Previous radiotherapy in the only site used to assess response. - Radiotherapy within the previous 4 weeks. - Active central nervous system disorder, brain metastasis or leptomeningeal involvement. - Symptomatic neuropathy (sensory) superior or equal to grade 2 according to the NCI Common Toxicity Criteria (NCI – CTC version 2). - Concomitant/uncontrolled medical disorder (superior cava vein syndrome, cardiac failure or myocardial infarction within the previous 3months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment). - Weight loss > 10% within the previous 3 months. - Long term oxygen therapy. - Symptomatic ascite or pericardial effusion. - History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. - Concomitant treatment with another anticancer or any experimentaldrug within 30 days prior to the treatment period. - Women if pregnant or lactating or with positive pregnancy test atinclusion; woman of child-bearing potential who did not use or is unwilling or unable to use an acceptable method of contraception to avoid pregnancy during the 2 months preceding the start of study treatment, for the entire study period and for up to 3 months after the last dose of oral vinorelbine or up to 6 months after the last dose of cisplatin; - Sexually active fertile man not using effective birth control during the study and up to 3 months following the last dose of oral vinorelbine or up to 6 months following the last dose of cisplatin or gemcitabine if his partner is a woman of child-bearing potential.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the Disease Control Rate (CR, PR, SD in both arma) on the whole study period (combination and manteinance periods).;Secondary Objective: Estimation of: -DCR at the end of combination period; -Objective Response Rate on the whole study period; -Objective Response Rate at the end of the combination period, -Duration of Disease Control; -Duration of Response; -Duration of Stable Disease; -Progression-Free Survival; -Time to treatment Failure; -Overall survival; -Tolerance; -Quality of Life (LCSS questionnaire); -Satisfaction Questionnaire.;Primary end point(s): Disease Control Rate (Tumour assessment);Timepoint(s) of evaluation of this end point: At baseline and every 6 weeks. After the completion of 4 cycles, in case of mantenaince treatment, assessment will be performed every 6 weeks (2 cycles)until disease progression.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Efficacy endpoints will be assessed by tumour assessment. Safety will be assessed by: -physical examination including vital signs, body weight and performance status. -complete blood cell count (WBC, neutrophils, haemoglobin and platelet counts). -Biochemistry. -Reporting adverse events using the NCI-CTC version 2.0 grading. -Quality of life questionnaire and satisfaction questionnaire.;Timepoint(s) of evaluation of this end point: Safety assessment will be performed at baseline, at each cycle, until end of study. Quality of life will be assessed at baseline, cycle 3 and 4 and at the end of study.