Adjuvant Chemotherapy of Pemetrexed/Carboplatin Compared With Vinorelbine/Carboplatin in Patients With Completely Resected NSCLC
Pemetrexed, a multi-target folate antimetabolite, shows clear activity in non-small cell
lung cancer (NSCLC). In a phase III study for patients with previously treated advanced
NSCLC, the efficacy of single-agent pemetrexed, as determined by overall survival, was
similar to that of docetaxel. (Hanna et al, 2004) The combination of carboplatin and
pemetrexed has been of particular interest because it has demonstrated both good efficacy
and a tolerable side effect profile. Phase I studies evaluated pemetrexed plus carboplatin
in patients with malignant pleural mesothelioma, showed the regimen was efficacious and well
tolerated. (Hughes et al, 2002) The combination of oxaliplatin and pemetrexed was compared
with carboplatin and pemetrexed as first-line therapy for advanced NSCLC in a randomized
phase II study. Response rates were 27 and 33%, respectively, and not statistically
different. Toxicity in the carboplatin/pemetrexed arm was low, this doublet can be delivered
easily and is well tolerated. Dose reductions occur only in 3.7% cycles. (Scagliotti et al,
2005) Therefore, it seems reasonable to test a less toxic regimen in patients with NSCLC
after complete (R0) resection of the tumor, where reduced toxicities might improve the
feasibility of drug delivery, compliance and the convenience of treatment for the patient
and hence perhaps improve survival. The main purpose of this randomized phase II trial is to
evaluate the clinical feasibility and activity of administering adjuvant chemotherapy of
pemetrexed/carboplatin compared with vinorelbine/carboplatin in patients with completely
resected NSCLC.
Observational
Time Perspective: Prospective
To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Carboplatin vs. Vinorelbine and Carboplatin
To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with Pemetrexed and Carboplatin vs. Vinorelbine and Carboplatin in patients with NSCLC stage IB, IIA, IIB and T3N1 (without need for further radiotherapy). Treatment is considered to have clinical feasibility if dose limiting toxicity (DLT) will not be observed, and no non-acceptance by the patient leading to premature withdrawal, and no death due to cancer or cancer therapy will occur.
1 month
Yes
China: Food and Drug Administration
PCVC001
NCT01258127
August 2010
August 2015
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