Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer

Trial ID #	NCT00002478
Phase	II
Drug Class	Chemotherapy
Drug Name	Etoposide
Alternate Drug Names	VePesid, Toposar, Lastet, epipodophyllotoxin
Drugs in Trial	Etoposide
Eligible Participant	Platinum resistant or refractory ovarian cancer (after first-line platinum-based chemotherapy)
Patients Enrolled	41
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, DoR, PFS, OS, evaluated per RECIST
Efficacy	ORR: 26.8% (3CR, 8PR, n=41) DoR: 4.3 months (1.3-8.7) PFS: 5.7 months (0.8-30.8) OS: 10.8 months (1.9-45.8)
Clinically Significant Adverse Events	Serious AE: Grade 3-4 AE: neutropenia (45%), leukopenia (41%), gastrointestional (15%), anemia (13%)
Conclusion	Prolonged etoposide regimen shows activity, but has hematologic toxicity
Reference	Rose PG et al. Prolonged Oral Etoposide as Second-Line Therapy for Platinum-Resistant and Platinum-Sensitive Ovarian Carcinoma: A Gynecologic Oncology Group Study. J Clin Oncol (1998) 16(2): 405-410 https://www.ncbi.nlm.nih.gov/pubmed/9469322