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
  Purpose

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 Intervention Phase
Non-Small Cell Lung Cancer
Drug: gemcitabine
Drug: cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 57
Study Start Date: November 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
monochemotherapy
Drug: gemcitabine
1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526643

Locations
Italy
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)
Investigators
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
  More Information

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00526643     History of Changes
Other Study ID Numbers: CAPPA-2, 2005-005631-97
Study First Received: September 6, 2007
Last Updated: July 29, 2013
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 02, 2014