Clinical trial NCT00526643: CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: stage IIIB
Stage IV
chemotherapy
monotherapy
combination chemotherapy
poor performance status
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
Collaborators: name: Clinical Trials Promoting Group (APRIC/CTPG)
name: Gruppo Oncologico del Lazio (GOL)
name: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
name: Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC)
name: Gruppo Oncologico Italia Meridionale
name: Northwest Oncology Cooperative Group(GONO)
First posted: 2007-09-10
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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)

Primary outcomes:
measure: overall survival
timeFrame: one year
Secondary outcomes:
measure: change in performance status
timeFrame: each cycle of chemotherapy
measure: toxicity
timeFrame: each cycle of chemotherapy and every 3 months thereafter
measure: quality of life
timeFrame: chemotherapy cycles 1 and 2
measure: objective response
timeFrame: at 6 weeks and 12 weeks
measure: progression free survival
timeFrame: one year
Other outcomes:
Locations:
city: Monteforte Irpino
country: Italy
facility: Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
state: AV
city: Acquaviva delle Fonti
country: Italy
facility: Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
state: BA
city: Bari
country: Italy
facility: Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
state: BA
city: Milano
country: Italy
facility: Istituto Scientifico S. Raffaele
state: MI
city: Mantova
country: Italy
facility: Azienda Ospedaliera C. Poma
state: MN
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
state: PD
city: Sondalo
country: Italy
facility: Ospedale E. Morelli
state: SO
city: Brindisi
country: Italy
facility: Ospedale Senatore Antonio Perrino
city: Catanzaro
country: Italy
facility: A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia
city: Isernia
country: Italy
facility: Ospedale F. Veneziale
city: Lecce
country: Italy
facility: A.O. Vito Fazzi
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
city: Parma
country: Italy
facility: Ospedale Regional, Unità Operative di Oncologia
city: Rome
country: Italy
facility: Ospedale San Camillo - Forlanini
city: San Felice a Cancello
country: Italy
facility: Ospedale S. Felice a Cancello
Study officials:
affiliation: APRIC/CTPG
name: Cesare Gridelli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
name: Luciano Frontini, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gruppo Oncologico Italia Meridionale
name: Vittorio Gebbia, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gruppo Oncologico Italiano di Ricerca Clinica
name: Andrea Ardizzoni, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: GOL
name: Filippo de Marinis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gruppo Oncologico del Nord-Ovest
name: Enrico Aitini, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Naples
name: Francesco Perrone, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: Ciro Gallo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.