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TerminatedNCT00526643CAPPA-2Updated Mar 28, 2017

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

A Phase 3 interventional study of gemcitabine and cisplatin in Non-Small Cell Lung Cancer, sponsored by National Cancer Institute, Naples. Terminated at 15 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-03-28.

Sponsored by National Cancer Institute, Naples · Phase 3, Interventional, and Treatment

Why this study was terminated
scarce enrolment and presentation of positive results of similar study in June 2012.
Phase
Phase 3
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • stage IIIB
  • Stage IV
  • chemotherapy
  • monotherapy
  • combination chemotherapy
  • poor performance status
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 57 is close to the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

National Cancer Institute, Naples is the lead sponsor of 112 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
57 participants (actual)

Study arms

  • Experimental
    Arm B

    combination chemotherapy

    Drug: gemcitabine · Drug: cisplatin

  • Active comparator
    Arm A

    monochemotherapy

    Drug: gemcitabine

Interventions

  • Druggemcitabine

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

  • Drugcisplatin

    cisplatin 60 mg/m2 on day 1 for 4 cycles

06

What researchers measure

Primary outcomes

  1. overall survival

    Time frame: one year

Secondary outcomes

  1. change in performance status

    Time frame: each cycle of chemotherapy

  2. toxicity

    Time frame: each cycle of chemotherapy and every 3 months thereafter

  3. quality of life

    Time frame: chemotherapy cycles 1 and 2

  4. objective response

    Time frame: at 6 weeks and 12 weeks

  5. progression free survival

    Time frame: one year

07

Study locations

15 sites
  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
    Monteforte Irpino, AV 83024, Italy
  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
    Acquaviva delle Fonti, BA 70021, Italy
  • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
    Bari, BA 70126, Italy
  • Istituto Scientifico S. Raffaele
    Milano, MI 20132, Italy
  • Azienda Ospedaliera C. Poma
    Mantova, MN 46100, Italy
  • Istituto Oncologico Veneto
    Padova, PD, Italy
  • Ospedale E. Morelli
    Sondalo, SO 23039, Italy
  • Ospedale Senatore Antonio Perrino
    Brindisi, Italy
  • A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia
    Catanzaro, Italy
  • Ospedale F. Veneziale
    Isernia, Italy
  • A.O. Vito Fazzi
    Lecce, Italy
  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
    Napoli, 80131, Italy
  • Ospedale Regional, Unità Operative di Oncologia
    Parma, Italy
  • Ospedale San Camillo - Forlanini
    Rome, Italy
  • Ospedale S. Felice a Cancello
    San Felice a Cancello, Italy
08

References and documents

Publications

  • 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. PubMed 23643177 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00526643
Lead sponsor
National Cancer Institute, Naples
Collaborators
Clinical Trials Promoting Group (APRIC/CTPG), Gruppo Oncologico del Lazio (GOL), Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC), Gruppo Oncologico Italia Meridionale, Northwest Oncology Cooperative Group(GONO)
Responsible party
Sponsor
First posted
Sep 10, 2007
Start date
Nov 2007
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Mar 28, 2017

Study contacts

Cesare Gridelli, M.D.
principal investigator · APRIC/CTPG
Luciano Frontini, M.D.
principal investigator · Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Vittorio Gebbia, M.D.
principal investigator · Gruppo Oncologico Italia Meridionale
Andrea Ardizzoni, M.D.
principal investigator · Gruppo Oncologico Italiano di Ricerca Clinica
Filippo de Marinis, M.D.
principal investigator · GOL
Enrico Aitini, M.D.
principal investigator · Gruppo Oncologico del Nord-Ovest
Francesco Perrone, M.D., Ph.D.
principal investigator · National Cancer Institute, Naples
Ciro Gallo, M.D., Ph.D.
principal investigator · University of Campania Luigi Vanvitelli

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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