Spots Global Cancer Trial Database for Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
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Trial Identification
Brief Title: Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
Official Title: Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
Study ID: NCT00786331
Conditions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Firenze, , 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, Milano, , 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
Contact Details
Name: Andrea Ardizzoni, MD
Affiliation: Gruppo Oncologico Italiano di Ricerca Clinica
Role: PRINCIPAL_INVESTIGATOR
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