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, PFS, OS, evaluated per RECIST

Efficacy

ORR: 21% (1CR, 9PR)
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