Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
NCT ID: NCT00786331
Last Updated: 2009-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
230 participants
INTERVENTIONAL
2007-07-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Monochemotherapy
Pemetrexed
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
B
Combination chemotherapy
Pemetrexed plus carboplatin
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
Interventions
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Pemetrexed
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
Pemetrexed plus carboplatin
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gruppo Oncologico Italiano di Ricerca Clinica
OTHER
Responsible Party
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GOIRC
Principal Investigators
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Andrea Ardizzoni, MD
Role: PRINCIPAL_INVESTIGATOR
Gruppo Oncologico Italiano di Ricerca Clinica
Locations
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Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
Ancona, , Italy
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica
Bergamo, , Italy
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica
Cremona, , Italy
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica
Cuneo, , Italy
Ospedale S. Croce, U.O. di Oncologia Medica
Fano, PU, , Italy
Azienda Ospedaliera Careggi, UO di Oncologia Medica
Florence, , Italy
EO Ospedali Galliera, SC Oncologia Medica
Genova, , Italy
Ospedale Versilia, UO di Oncologia Medica
Lido Di Camaiore, LU, , Italy
USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda
Livorno, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica
Meldola, FC, , Italy
Istituto Nazionale Tumori, SC di Oncologia 2
Milan, , Italy
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia
Modena, , Italy
AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica
Monza, MI, , Italy
Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica
Parma, , Italy
Ospedale Silvestrini, S.C. di Oncologia Medica
Perugia, , Italy
Arcispedale Santa Maria Nuova, UO di Oncologia Medica
Reggio Emilia, , Italy
Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica
Roma, , Italy
Ospedale SS. Annunziata, UO di Oncologia Medica
Sassari, , Italy
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica
Torino, , Italy
P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica
Treviglio, BG, , Italy
Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata
Verona, , Italy
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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EudraCT number 2006-004009-24
Identifier Type: -
Identifier Source: secondary_id
GOIRC 02/2006
Identifier Type: -
Identifier Source: org_study_id
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