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

Non-Small Cell Lung Cancer Clinical Trial

— CAPPA-2  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00526643
• Other study ID #: CAPPA-2
• Secondary ID: 2005-005631-97
• Status: Terminated
• Phase: Phase 3
• First received: September 6, 2007
• Last updated: March 27, 2017
• Start date: November 2007
• Est. completion date: December 2012

Study information

• Verified date: March 2017
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• gemcitabine
1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles
• cisplatin
cisplatin 60 mg/m2 on day 1 for 4 cycles

Locations

Country	Name	City	State
Italy	Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica	Acquaviva delle Fonti	BA
Italy	Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale	Bari	BA
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	Azienda Ospedaliera C. Poma	Mantova	MN
Italy	Istituto Scientifico S. Raffaele	Milano	MI
Italy	Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica	Monteforte Irpino	AV
Italy	Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B	Napoli
Italy	Istituto Oncologico Veneto	Padova	PD
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	Ospedale E. Morelli	Sondalo	SO

Sponsors (7)

Lead Sponsor	Collaborator
National Cancer Institute, Naples	Clinical Trials Promoting Group (APRIC/CTPG), Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico del Lazio (GOL), Gruppo Oncologico Italia Meridionale, Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC), Northwest Oncology Cooperative Group(GONO)

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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, P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		one year
Secondary	change in performance status		each cycle of chemotherapy
Secondary	toxicity		each cycle of chemotherapy and every 3 months thereafter
Secondary	quality of life		chemotherapy cycles 1 and 2
Secondary	objective response		at 6 weeks and 12 weeks
Secondary	progression free survival		one year