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 epipodophyllotoxin, Lastet, Toposar, VePesid
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