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

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