A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma

Trial ID #	NCT00087087
Phase	II
Drug Class	Chemotherapy
Drug Name	Pemetrexed
Alternate Drug Names	Pemetrexed disodium, Alimta
Drugs in Trial	Pemetrexed
Eligible Participant	Primary platinum resistant or refractory ovarian cancer
Patients Enrolled	51; median 4 prior therapies
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DCR, DoR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 21% (1CR, 9PR) DCR: % (1CR, 9PR, 17SD) DoR: 8.4 months PFS: 2.9 months OS:11.4 months
Clinically Significant Adverse Events	Serious AE: none Grade 3-4 AE: neutropenia (42%), leukopenia (25%), anemia (15%), constitutional (15%)
Conclusion	Favorable antitumor activity with mild and non-cumulative toxicity
Reference	Miller DS et al. Phase II evaluation of pemetrexed in the treatment of recurrent or persistent platinum-resistant ovarian or primary peritoneal carcinoma: a study of the Gynecologic Oncology Group. J Clin Oncol (2009) 27(16):2686-91 https://www.ncbi.nlm.nih.gov/pubmed/19332726