advanced non small cell lung cancer (stage IIIB-IV) MedDRA version: 9.1 Level: LLT Classification code 10029522
Conditions
Interventions
Trade Name: GEMZAR*INF ENDOVESC 1FL 1G
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Gemcitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10
Sponsors
ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE "G. PASCALE"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Diagnosis of cytologically or histologically confirmed non small cell lung cancer. ? Metastatic (stage IV) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes or with pleural effusion). ? Patients at first diagnosis or those with disease recurrence after former surgery are eligible. ? At least one target or non-target lesion according to RECIST. ? Male or female ? 70 years of age . ? Performance status according to ECOG 0 or 1 (see Annex, table 1). ? Life expectancy of > 3 months. ? Neutrophils ? 1.5 x 109/L, platelets ? 100 x 109/L, and hemoglobin ? 10 g/dL. ? Bilirubin level either normal or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced NSCLC. Prior surgery and/or localised irradiation is permitted. Prior adjuvant chemotherapy is permitted if at least 1 year elapsed from the end of adjuvant chemotherapy and the date of relapse. ? Any unstable systemic disease (including active infections, significant cardiovascular disease or myocardial infarction within the previous year, any significant hepatic, renal or metabolic disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medications. ? Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA). ? Patients are excluded if they have symptomatic brain metastases or spinal cord compression. (Note: Such patients can be included after treatment with surgery and/or radiation. Patients with asymptomatic brain metastases can be included, even if on anti-seizure medications). ? Known or suspected hypersensitivity to any of the study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to test whether the addition of cisplatin to gemcitabine prolongs overall survival as compared to gemcitabine alone, based on a superiority survival comparison.;Secondary Objective: Secondary objectives are to compare toxicity, progression-free survival, response rate and quality of life between the two arms.;Primary end point(s): OVERALL SURVIVAL | — |
Countries
Italy
Outcome results
None listed