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

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

DRUG

gemcitabine

1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

DRUG

cisplatin

cisplatin 60 mg/m2 on day 1 for 4 cycles

Sponsors & Collaborators

• Clinical Trials Promoting Group (APRIC/CTPG)

  collaborator UNKNOWN

• Gruppo Oncologico del Lazio (GOL)

  collaborator UNKNOWN

• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

  collaborator OTHER

• Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC)

  collaborator UNKNOWN

• Gruppo Oncologico Italia Meridionale

  collaborator OTHER

• Northwest Oncology Cooperative Group(GONO)

  collaborator UNKNOWN

• National Cancer Institute, Naples

  lead OTHER

Principal Investigators

• Cesare Gridelli, M.D. · APRIC/CTPG

• Luciano Frontini, M.D. · Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

• Vittorio Gebbia, M.D. · Gruppo Oncologico Italia Meridionale

• Andrea Ardizzoni, M.D. · Gruppo Oncologico Italiano di Ricerca Clinica

• Filippo de Marinis, M.D. · GOL

• Enrico Aitini, M.D. · Gruppo Oncologico del Nord-Ovest

• Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

• Ciro Gallo, M.D., Ph.D. · University of Campania Luigi Vanvitelli

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2012-12-31

Completion

2012-12-31

Countries

• Italy

Study Locations