Feasibility study of two schedules of sunitinib in combination with pemetrexed in patients with advanced solid tumors

Isamu Okamoto, Toshio Shimizu, Masaki Miyazaki, Junji Tsurutani, Yasuko Ichikawa, Masaki Terashima, Masayuki Takeda, Soichi Fumita, Emiko Ohki, Nobuyuki Kimura, Junichi Hashimoto, Kazuhiko Nakagawa

Research output: Contribution to journalArticlepeer-review

7 Citations (Scopus)


Background: Sunitinib is an oral multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, as well as of other receptor types. We have performed a feasibility study to investigate the safety of sunitinib in combination with pemetrexed for treatment of advanced refractory solid tumors. Methods: Sunitinib was administered once daily on a continuous daily dosing (CDD) schedule (37.5 mg/day) or a 2-weeks-on, 1-week-off treatment schedule (50 mg/day, Schedule 2/1) in combination with pemetrexed at 500 mg/m 2 on day 1 of repeated 21-day cycles. Results: Twelve patients were enrolled in the study: six on the CDD schedule and six on Schedule 2/1. None of the treated patients experienced a dose-limiting toxicity. Toxicities were manageable and similar in type to those observed in monotherapy studies of sunitinib and pemetrexed. Pharmacokinetic analysis did not reveal any substantial drug-drug interaction. One patient with squamous cell lung cancer showed a partial response and five patients had stable disease. Conclusions: Combination therapy with sunitinib administered on Schedule 2/1 (50 mg/day) or a CDD schedule (37.5 mg/day) together with standard-dose pemetrexed (500 mg/m 2) was well tolerated in previously treated patients with advanced solid tumors.

Original languageEnglish
Pages (from-to)639-646
Number of pages8
JournalInvestigational New Drugs
Issue number2
Publication statusPublished - Apr 2012
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Oncology
  • Pharmacology
  • Pharmacology (medical)


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