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

Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)

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.

Performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer (NSCLC), regardless of treatment received. Chemotherapy is recommended for advanced NSCLC patients in good clinical condition, but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition (performance status 2). This category of patients represents about 20% of all patients at initial diagnosis of NSCLC, and remains a treatment challenge for the clinician. There have been very few studies that have evaluated the impact of chemotherapy for this group of patients, and there is no established standard therapy. Studies evaluating single agent and combination two-agent chemotherapy regimens' impact on survival and improving symptoms are needed.

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)