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

March 27, 2017 updated by: National Cancer Institute, Naples

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brindisi, Italy
        • Ospedale Senatore Antonio Perrino
      • Catanzaro, Italy
        • A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia
      • Isernia, Italy
        • Ospedale F. Veneziale
      • Lecce, Italy
        • A.O. Vito Fazzi
      • Napoli, Italy, 80131
        • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
      • Parma, Italy
        • Ospedale Regional, Unità Operative di Oncologia
      • Rome, Italy
        • Ospedale San Camillo - Forlanini
      • San Felice a Cancello, Italy
        • Ospedale S. Felice a Cancello
    • AV
      • Monteforte Irpino, AV, Italy, 83024
        • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
    • BA
      • Acquaviva delle Fonti, BA, Italy, 70021
        • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
      • Bari, BA, Italy, 70126
        • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
    • MI
      • Milano, MI, Italy, 20132
        • Istituto Scientifico S. Raffaele
    • MN
      • Mantova, MN, Italy, 46100
        • Azienda Ospedaliera C. Poma
    • PD
      • Padova, PD, Italy
        • Istituto Oncologico Veneto
    • SO
      • Sondalo, SO, Italy, 23039
        • Ospedale E. Morelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
monochemotherapy
Drug: gemcitabine
1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: one year
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Naples

Collaborators

Gruppo Oncologico Italia Meridionale
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Clinical Trials Promoting Group (APRIC/CTPG)
Gruppo Oncologico del Lazio (GOL)
Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC)
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 6, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPPA-2
  • 2005-005631-97 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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