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

This study is ongoing, but not recruiting participants.
Sponsor:
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)
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00526643
First received: September 6, 2007
Last updated: July 29, 2013
Last verified: July 2013

September 6, 2007
July 29, 2013
November 2007
December 2013   (final data collection date for primary outcome measure)
overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
overall survival
Complete list of historical versions of study NCT00526643 on ClinicalTrials.gov Archive Site
  • change in performance status [ Time Frame: each cycle of chemotherapy ] [ Designated as safety issue: No ]
  • toxicity [ Time Frame: each cycle of chemotherapy and every 3 months thereafter ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: chemotherapy cycles 1 and 2 ] [ Designated as safety issue: No ]
  • objective response [ Time Frame: at 6 weeks and 12 weeks ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
  • change in performance status [ Time Frame: each cycle of chemotherapy ]
  • toxicity [ Time Frame: each cycle of chemotherapy and every 3 months thereafter ]
  • quality of life [ Time Frame: chemotherapy cycles 1 and 2 ]
  • objective response [ Time Frame: at 6 weeks and 12 weeks ]
  • progression free survival
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • 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
  • Experimental: Arm B
    combination chemotherapy
    Interventions:
    • Drug: gemcitabine
    • Drug: cisplatin
  • Active Comparator: Arm A
    monochemotherapy
    Intervention: Drug: gemcitabine
Morabito A, Gebbia V, Di Maio M, Cinieri S, Viganò 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
57
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00526643
CAPPA-2, 2005-005631-97
No
National Cancer Institute, Naples
National Cancer Institute, Naples
  • 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)
Principal Investigator: Cesare Gridelli, M.D. APRIC/CTPG
Principal Investigator: Luciano Frontini, M.D. Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Principal Investigator: Vittorio Gebbia, M.D. Gruppo Oncologico Italia Meridionale
Principal Investigator: Andrea Ardizzoni, M.D. Gruppo Oncologico Italiano di Ricerca Clinica
Principal Investigator: Filippo de Marinis, M.D. GOL
Principal Investigator: Enrico Aitini, M.D. Gruppo Oncologico del Nord-Ovest
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: Ciro Gallo, M.D., Ph.D. Second University of Naples
National Cancer Institute, Naples
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP