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Non-Small Cell Lung CancerPhase 3CAPPA-2NCT00526643

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

A Phase 3 study testing gemcitabine and cisplatin in people with Non-Small Cell Lung Cancer, run by National Cancer Institute, Naples at 15 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
gemcitabine and cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
15 sitesItaly
Study dates
Nov 2007to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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)

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Italy15 sites

  • Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

    Acquaviva delle Fonti, BA, 70021

  • Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale

    Bari, BA, 70126

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia

    Catanzaro

  • Ospedale F. Veneziale

    Isernia

  • A.O. Vito Fazzi

    Lecce

  • Azienda Ospedaliera C. Poma

    Mantua, MN, 46100

  • Istituto Scientifico S. Raffaele

    Milan, MI, 20132

  • Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

    Monteforte Irpino, AV, 83024

  • Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

    Naples, 80131

  • Istituto Oncologico Veneto

    Padova, PD

  • Ospedale Regional, Unità Operative di Oncologia

    Parma

  • Ospedale San Camillo - Forlanini

    Rome

  • Ospedale S. Felice a Cancello

    San Felice A Cancello

  • Ospedale E. Morelli

    Sondalo, SO, 23039

Other trials in Italy

About this study

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)

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.

Read the 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.

Being tested
gemcitabine, cisplatin
Keywords
stage IIIB, Stage IV, chemotherapy, monotherapy, combination chemotherapy, poor performance status
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gemcitabineDrug

    1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

  • cisplatinDrug

    cisplatin 60 mg/m2 on day 1 for 4 cycles

Study groups in NCT00526643
Study groupRoleWhat they receive
Arm BExperimentalcombination chemotherapy
Receives: Drug: gemcitabine; Drug: cisplatin
Arm AActive comparatormonochemotherapy
Receives: Drug: gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    Measured: one year

Secondary outcomes (5)

  1. change in performance status

    Measured: each cycle of chemotherapy

  2. toxicity

    Measured: each cycle of chemotherapy and every 3 months thereafter

  3. quality of life

    Measured: chemotherapy cycles 1 and 2

  4. objective response

    Measured: at 6 weeks and 12 weeks

  5. progression free survival

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionDec 2012
  4. Study completionDec 2012

Why it stopped: scarce enrolment and presentation of positive results of similar study in June 2012.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00526643
Sponsor's protocol ID
CAPPA-2
Other IDs
2005-005631-97, 2005
Acronym
CAPPA-2
Status last verified
Mar 2017
First submitted
6 Sep 2007
Last updated
28 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Morabito A, Gebbia V, Di Maio M, Cinieri S, Vigano 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, Perrone F. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: the CAPPA-2 study. Lung Cancer. 2013 Jul;81(1):77-83. doi: 10.1016/j.lungcan.2013.04.008. Epub 2013 May 1.

    PubMed 23643177

  • Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.

    PubMed 37419867

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine and cisplatin in people with Non-Small Cell Lung Cancer, run by National Cancer Institute, Naples at 15 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: scarce enrolment and presentation of positive results of similar study in June 2012.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00526643, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.

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CAPPA-2 Clinical Trial NCT00526643 | AzTrials