drugset / Trial / NCT00526643
CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients
Phase 3
Terminated
57 enrolled
National Cancer Institute, Naples
Clinical Trials Promoting Group (APRIC/CTPG) · collabGruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente · collabGruppo Oncologico Italia Meridionale · collabGruppo Oncologico Italiano di Ricerca Clinica(GOIRC) · collabGruppo Oncologico del Lazio (GOL) · collabNorthwest Oncology Cooperative Group(GONO) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-11
- Primary completion
- 2012-12
- Completion
- 2012-12
Outcome
Met primary endpoint
Stopped: “scarce enrolment and presentation of positive results of similar study in June 2012.”
paper Median OS was 3.0 months with single-agent gemcitabine and 5.9 months with cisplatin plus gemcitabine (HR 0.52, 95% CI 0.28-0.98, p = 0.039). PMID 23643177 ↗
Publications
- Results Morabito A, Gebbia V, Di Maio M, Cinieri S, Vigano MG, Bianco R, Barbera S, Cavanna L, De Marinis F, Montesarchio V, Costanzo R, Sandomenico C, Montanino A, Mancuso G, Russo P, Nacci A, Giordano P, Daniele G, Piccirillo MC, Rocco G, Gridelli C, Gallo C, Perrone F. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: the CAPPA-2 study. Lung Cancer. 2013 Jul;81(1):77-83. doi: 10.1016/j.lungcan.2013.04.008. Epub 2013 May 1.
- Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | — |