Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC
Andrea Ardizzoni, MD
Gruppo Oncologico Italiano di Ricerca Clinica
Italy: Ministry of Health