Patients with stage IIIB with pleural effusion or stage IV NSCLC with documented disease progression during or after completion of docetaxel-based treatment are eligible for the study.
Conditions
Sponsors
Hellenic Oncology Research Group (H.O.R.G.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age>18 years old -Cytologically or histologically documented NSCLC -PS 0-2 (WHO scale) -Measurable disease according to RECIST v1.1 (at least one measurable lesion) -Documented disease progression to previous treatment with docetaxel regimen in 1st or 2nd line setting assessed by Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) with at least one visceral or soft-tissue metastatic lesion. -Brain metastases are allowed, given that are clinically stable and the patient does not present neurologic symptoms. -Previous radiotherapy, either in the adjuvant setting or for the treatment of bone metastases, is allowed provided that the measurable lesions are outside the radiation fields. Patients who were irradiated to = 40% of bone marrow are not eligible for the study. -Patients must have a recent (within 7 days prior to treatment start) biochemical and hematogical assessment as defined by adequate bone marrow (absolute neutrophil count =1.5 x 109 cells/L, platelets =100 x 109cells/L and hemoglobin =9 g/dL), liver (AST&ALT = 2.5x ULN, total bilirubin within normal range) and renal (serum creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Persistence of clinically relevant treatment-related toxicities from previous chemotherapy or radiotherapy. -Treatment with other investigational drugs or treatment in another clinical trial within the past four weeks before start of treatment or concomitantly with this trial. -Other malignancy within the past five years other than basal cell skin cancer or carcinoma in situ of the cervix. -Patient with reproductive potential not implementing accepted and effective method of contraception -History of severe hypersensitivity reaction (=grade 3) to polysorbate 80 containing drugs or to docetaxel - Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus, hypertension, heart failure = NYHA II, history of myocardial infarction within the past 6 months, angina, chronic obstructive pulmonary disease (COPD), serious infections requiring systemic antibiotic therapy (e.g. antimicrobial, antifungal, antiviral) -Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (a one week wash-out period is necessary for patients who are already on these treatments) (see Appendix A and B) - Prior surgery, radiation, chemotherapy, within 4 weeks prior to treatment - Active grade =2 peripheral neuropathy - Active grade =2 stomatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Response Rate (ORR), defined as the proportion of patients with complete or partial response according to RECIST version 1.1 [17]. Given that the objective response rate from randomized phase III trials with agents active in the second line setting ranges from about 7-10%[9,10,8,11,12], a minimum objective response rate of 8% will be required in order to consider that the drug is potentially active and requires further evaluation.;Secondary Objective: i) Time to response, defined as the time interval between the date of enrollment and the date of the criteria of complete or partial response are met for the first time. ii) Disease control rate (DCR), defined as the proportion of patients with complete response+ partial response + stable disease. iii) Progression free survival (PFS), defined as the time interval between the date of enrollment and the date of disease progression or death (any cause). iv) Overall survival (OS), defined as the time interval between the date of enrollment and the date of death. v) Toxicity profile;Primary end point(s): Overall Response Rate (ORR), defined as the proportion of patients with complete or partial response according to RECIST version 1.1 [17]. Given that the objective response rate from randomized phase III trials with agents active in the second line setting ranges from about 7-10%[9,10,8,11,12], a minimum objective response rate of 8% will be required in order to consider that the drug is potentially active and requires further evaluation.;Timepoint(s) of evaluation of this end point: 2 months after the first visit of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): i) Time to response, defined as the time interval between the date of enrollment and the date of the criteria of complete or partial response are met for the first time. ii) Disease control rate (DCR), defined as the proportion of patients with complete response+ partial response + stable disease. iii) Progression free survival (PFS), defined as the time interval between the date of enrollment and the date of disease progression or death (any cause). iv) Overall survival (OS), defined as the time interval between the date of enrollment and the date of death. v) Toxicity profile;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Countries
Greece
Contacts
Public ContactIoannis Athanasakis
University Hospital of Heraklion
Outcome results
None listed