A Randomized Open Label Phase II Study of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Patients With Persistent or Relapsed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma

Trial ID # NCT01610206
Phase II
Drug Class Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name Pazopanib
Alternate Drug Names Votrient
Drugs in Trial Gemcitabine, Pazopanib
Eligible Participant

Recurrent or persistent ovarian cancer

Patients Enrolled

148

Therapy Setting

Recurrence

Study Design

Open-Label, Randomized

Endpoints

ORR, DCR, PFS, evaluated per RECIST

Efficacy

Paz+Gem vs Gem:

ORR: 20 vs 11%, p=0.02
DCR: 80 vs 60%, p<0.001
PFS: 5.3 vs  2.9 months

Exploratory analysis: Pt-R patients:
Paz+Gem vs Gem:
PFS: 5.32 vs 2.33 months, p<0.001

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE:

Conclusion

The addition of pazopanib to gemcitabine enhances the anti-tumor activity, in particular in patients with Pt-R disease

Reference

Duska LR et al. A Randomized Phase II Evaluation of Weekly Gemcitabine Plus Pazopanib Versus Weekly Gemcitabine Alone in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma. Gynecol Oncol (2020) 157(3):585-592
https://pubmed.ncbi.nlm.nih.gov/32247603/

Contact Us
Contact Us

We are here to help! Send us a message below or give us a call at (858) 657-0282.