CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute, Naples
• Collaborators: Clinical Trials Promoting Group (APRIC/CTPG); Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente; Gruppo Oncologico del Lazio (GOL); Gruppo Oncologico Italia Meridionale; Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC); Northwest Oncology Cooperative Group(GONO)
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV);

• No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment);

• ECOG performance status 2;

• Age: > or = 18 and < 70 years;

• Life expectancy at least 4 weeks;

• Normal bone marrow, hepatic and renal function defined as: neutrophils > or = 2000/mm3, PLT > or = 100,000/mm3, Hb > or = 10.0 g/dl, Bilirubin > or = 1.5 times the upper normal limit (UNL), AST and ALT < or = 3 times the UNL (5 times in the presence of liver metastases), creatinine within normal limits;

• Signed informed consent.

Exclusion Criteria:

• Active systemic infections;

• Severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus);

• Inadequate hepatic or renal function;

• Radiation therapy ongoing or concluded within two weeks prior to enrollment;

• Symptomatic cerebral metastases;

• Previous chemotherapy for advanced disease;

• Any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures;

• Pregnant or nursing females;

• Any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)