Overview

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)