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Advanced Non-Small Cell Lung CancerPhase 2NCT00786331

Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

A Phase 2 study testing Pemetrexed and Pemetrexed plus carboplatin in people with Advanced Non-Small Cell Lung Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 21 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Pemetrexed and Pemetrexed plus carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
21 sitesItaly
Study dates
Jul 2007to Dec 2009
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • written informed consent
  • Histologically or cytologically confirmed non-small-cell lung cancer
  • Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic disease, with evidence of disease progression after first line chemotherapy which should have included a platinum agent.
  • ECOG performance status lower than or equal to 2
  • Adequate hematological, hepatic and renal functions
  • Life expectancy greater than or equal to 12 weeks
  • Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent
  • At baseline, presence of at least one measurable target lesion as per RECIST criteria

Who cannot join

  • Prior treatment with pemetrexed.
  • Patients who are pregnant or lactating
  • Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled.
  • Symptomatic brain metastases
  • History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Concomitant treatment with any other anticancer drug.

Trial locations and contacts

21 sites in 1 country.

Luca Boni, MD contact

+39 0557947553

bonil@aou-careggi.toscana.it

21 sites in 1 country

Italy21 sites, 20 recruiting

  • Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica

    Ancona, 60020

    Active, not recruiting

  • Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica

    Bergamo, 24128

    Roberto Labianca, MD

    Recruiting

  • Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica

    Cremona, 26100

    Rodolfo Passalacqua, MD

    Recruiting

  • Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica

    Cuneo, 12100

    Marco Merlano, MD

    Recruiting

  • Ospedale S. Croce, U.O. di Oncologia Medica

    Fano, PU, 61032

    Rodolfo Mattioli, MD

    Recruiting

  • Azienda Ospedaliera Careggi, UO di Oncologia Medica

    Florence, 50139

    Francesco Di Costanzo, MD

    Recruiting

  • EO Ospedali Galliera, SC Oncologia Medica

    Genova, 16128

    Andrea Decensi, MD

    Recruiting

  • Ospedale Versilia, UO di Oncologia Medica

    Lido Di Camaiore, LU, 55043

    Domenico Amoroso, MD

    Recruiting

  • USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda

    Livorno, 57122

    Alfredo Falcone, MD

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica

    Meldola, FC, 47014

    Dino Amadori, MD

    Recruiting

  • Istituto Nazionale Tumori, SC di Oncologia 2

    Milan, 20133

    Emilio Baietta, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia

    Modena, 41100

    Fausto Barbieri, MD

    Recruiting

  • AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica

    Monza, MI, 20052

    Paolo Bidoli, MD

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica

    Parma, 43100

    Andrea Ardizzoni, MD

    Recruiting

  • Ospedale Silvestrini, S.C. di Oncologia Medica

    Perugia, 06156

    Lucio Crinò, MD

    Recruiting

  • Arcispedale Santa Maria Nuova, UO di Oncologia Medica

    Reggio Emilia, 42100

    Corrado Boni, MD

    Recruiting

  • Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica

    Roma, 00151

    Filippo De Marinis, MD

    Recruiting

  • Ospedale SS. Annunziata, UO di Oncologia Medica

    Sassari, 07100

    Antonio Contu, MD

    Recruiting

  • Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica

    Torino, 10126

    Libero Ciuffreda, MD

    Recruiting

  • P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica

    Treviglio, BG, 24047

    Barni Sandro, MD

    Not yet recruiting

  • Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata

    Verona, 37126

    Antonio Santo, MD

    Recruiting

Other trials in Italy

About this study

Official title: Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).

The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC.

Read the detailed description

In spite of the superiority of single agent over best supportive care in second-line NSCLC, the prognosis of these patients remains poor with a median survival of 6-7 months, justifying the evaluation of new regimens in this setting. An open question in the second-line treatment of NSCLC remains the possible superiority of combination chemotherapy over single agent, as it has been clearly demonstrated in first-line. Particularly, the addition of platinum to either docetaxel or pemetrexed should be further investigated especially in patients with prior response/stable disease to platinum-based first-line chemotherapy. Pemetrexed has shown anti-tumor activity in combination with other chemotherapy agents, including gemcitabine, vinorelbine, taxanes, cisplatin and carboplatin. In this multicenter, open label, randomized phase II trial, pemetrexed 500 mg/m2 and carboplatin AUC 5 will be administered on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses in the experimental arm. The control arm will be pemetrexed as single agent at 500 mg/m2 on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses.

Being tested
Pemetrexed, Pemetrexed plus carboplatin
Keywords
second line treatment, pemetrexed, carboplatin

What participants receive

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

  • PemetrexedDrug

    Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle

  • Pemetrexed plus carboplatinDrug

    Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle

Study groups in NCT00786331
Study groupRoleWhat they receive
AActive comparatorMonochemotherapy
Receives: Drug: Pemetrexed
BExperimentalCombination chemotherapy
Receives: Drug: Pemetrexed plus carboplatin

What is being measured

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

  1. To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC

    Measured: 36 months

Secondary outcomes (4)

  1. To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.

    Measured: 3 months

  2. To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.

    Measured: 36 months

  3. To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.

    Measured: 3 months

  4. To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.

    Measured: 36 months

Timeline

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

  1. First posted6 Nov 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionJul 2009 (estimated)
  4. Study completionDec 2009 (estimated)

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00786331
Sponsor's protocol ID
GOIRC 02/2006
Other IDs
EudraCT number 2006-004009-24
Status last verified
Jul 2009
First submitted
1 Jul 2008
Last updated
3 Aug 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • van Kruijsdijk RC, Visseren FL, Boni L, Groen HJ, Dingemans AM, Aerts JG, van der Graaf Y, Ardizzoni A, Smit EF. Pemetrexed plus carboplatin versus pemetrexed in pretreated patients with advanced non-squamous non-small-cell lung cancer: treating the right patients based on individualized treatment effect prediction. Ann Oncol. 2016 Jul;27(7):1280-6. doi: 10.1093/annonc/mdw154. Epub 2016 Apr 6.

    PubMed 27052652

  • Ardizzoni A, Tiseo M, Boni L, Vincent AD, Passalacqua R, Buti S, Amoroso D, Camerini A, Labianca R, Genestreti G, Boni C, Ciuffreda L, Di Costanzo F, de Marinis F, Crino L, Santo A, Pazzola A, Barbieri F, Zilembo N, Colantonio I, Tibaldi C, Mattioli R, Cafferata MA, Camisa R, Smit EF. Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer: results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial. J Clin Oncol. 2012 Dec 20;30(36):4501-7. doi: 10.1200/JCO.2012.43.6758. Epub 2012 Oct 29.

    PubMed 23109689

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed and Pemetrexed plus carboplatin in people with Advanced Non-Small Cell Lung Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 21 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Luca Boni, MD (+39 0557947553, bonil@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC (time frame: 36 months). 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 NCT00786331, 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 3 Aug 2009.

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