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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00526643
Recruitment Status : Terminated (scarce enrolment and presentation of positive results of similar study in June 2012.)
First Posted : September 10, 2007
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: gemcitabine Drug: cisplatin Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2007
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm B
combination chemotherapy
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
Active Comparator: Arm A
Drug: gemcitabine
1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: one year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00526643

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Monteforte Irpino, AV, Italy, 83024
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Acquaviva delle Fonti, BA, Italy, 70021
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Bari, BA, Italy, 70126
Istituto Scientifico S. Raffaele
Milano, MI, Italy, 20132
Azienda Ospedaliera C. Poma
Mantova, MN, Italy, 46100
Istituto Oncologico Veneto
Padova, PD, Italy
Ospedale E. Morelli
Sondalo, SO, Italy, 23039
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, Italy, 80131
Ospedale Regional, Unità Operative di Oncologia
Parma, Italy
Ospedale San Camillo - Forlanini
Rome, Italy
Ospedale S. Felice a Cancello
San Felice a Cancello, Italy
Sponsors and Collaborators
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. University of Campania "Luigi Vanvitelli"
More Information

Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00526643     History of Changes
Other Study ID Numbers: CAPPA-2
2005-005631-97 ( EudraCT Number )
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by National Cancer Institute, Naples:
stage IIIB
Stage IV
combination chemotherapy
poor performance status

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs