Small cell lung cancer MedDRA version: 9.1 Level: LLT Classification code 10059514 Term: Small cell lung cancer metastatic
Conditions
Interventions
Trade Name: VEPESID*IV 1F 5ML 100MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Etoposide
CAS Number: 33419-42-0
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cytologic or hystologic diagnosis of SCLC; Extended stage of disease; at least one target lesion; Performance status (ECOG) 0 - 1; age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previuos chemotherapy; previous or concomitant malignancy; Neutrophils 1.5 x ULN; AST (SGOT) and ALT (SGPT)> 2.5 x ULN; Serum creatinine > 1.5 x ULN; hypersensitivity to darbepoetin alfa, r-HuEPO or any inactive ingredients; uncontrolled hypertension.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the activity (in terms of objective responses)of a chemotherapy regimen (cisplatin in combination with etoposide) based on ?toxicity ? adjusted dosing?, with a chemotherapy regimen containing the same drugs at standard doses, as first-line therapy of patients affected by advanced SCLC.;Secondary Objective: To describe the feasibility of ?toxicity ? adjusted dosing? regimen, in terms of dose levels and toxicity; to compare the two regimens in terms of progression-free survival and overall survival; to describe the treatment of anemia with darbepoetin alfa, in terms of patients who need the treatment, levels of haemoglobin during the study, number of required blood cell transfusions, compliance to chemotherapy.;Primary end point(s): na | — |
Countries
Italy
Outcome results
None listed