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

Phase 3

Terminated

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: gemcitabine; Drug: cisplatin

• Registration Number: NCT00526643
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study First Submitted: 2007-09-06
• Study First Submitted QC: 2007-09-06
• Study First Posted: 2007-09-10
• Study Start: 2007-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	gemcitabine	combination chemotherapy
Arm B	cisplatin	combination chemotherapy
Arm A	gemcitabine	monochemotherapy

Primary Outcome Measures

Name	Time	Method
overall survival	one year

Secondary Outcome Measures

Name	Time	Method
change in performance status	each cycle of chemotherapy
toxicity	each cycle of chemotherapy and every 3 months thereafter
quality of life	chemotherapy cycles 1 and 2
objective response	at 6 weeks and 12 weeks
progression free survival	one year

Trial Locations

Locations (15)

Istituto Scientifico S. Raffaele; 🇮🇹 Milano, MI, Italy

Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale; 🇮🇹 Bari, BA, Italy

Azienda Ospedaliera C. Poma; 🇮🇹 Mantova, MN, Italy

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica; 🇮🇹 Monteforte Irpino, AV, Italy

A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia; 🇮🇹 Catanzaro, Italy

A.O. Vito Fazzi; 🇮🇹 Lecce, Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B; 🇮🇹 Napoli, Italy

Ospedale E. Morelli; 🇮🇹 Sondalo, SO, Italy

Ospedale San Camillo - Forlanini; 🇮🇹 Rome, Italy

Ospedale Senatore Antonio Perrino; 🇮🇹 Brindisi, Italy

Ospedale F. Veneziale; 🇮🇹 Isernia, Italy

Ospedale Regional, Unità Operative di Oncologia; 🇮🇹 Parma, Italy

Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica; 🇮🇹 Acquaviva delle Fonti, BA, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, PD, Italy

Ospedale S. Felice a Cancello; 🇮🇹 San Felice a Cancello, Italy