Paclitaxel and Carboplatin With Or Without Sorafenib In The First-Line Treatment Of Patients With Ovarian Cancer

Status:	Archived
Conditions:	Ovarian Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

A Randomized Phase II Study of Paclitaxel/Carboplatin With or Without Sorafenib in the First-Line Treatment of Patients With Stage III/IV Epithelial Ovarian Cancer

This trial will compare the efficacy and toxicity of standard first-line chemotherapy alone
vs. standard chemotherapy + sorafenib in patients with stage III/IV ovarian cancer following
cytoreductive surgery. Patients with residual large volume disease and/or bowel involvement
will be excluded, to minimize the risk of bowel perforation.

All patients must be at least 4 weeks from cytoreductive surgery before starting treatment.
Patients will be randomized to receive treatment with either paclitaxel/carboplatin +
sorafenib or paclitaxel/carboplatin. Paclitaxel/carboplatin will be repeated every 21 days
for a maximum of 6 cycles. Patients with objective response/stable disease after completing
6 courses of chemotherapy will continue sorafenib until disease progression or for a total
of 12 months.

- Regimen A: Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over
20 minutes IV, Day 1 Sorafenib 400mg PO bid

- Regimen B: Paclitaxel 175mg/m2, 1-3 hour IV infusion, Day 1 Carboplatin AUC 6.0, 20 minute
IV infusion, Day 1

We found this trial at

sites

Gulfcoast Oncology Associates

1099 5th Avenue North
St. Petersburg, Florida 33705

from

St. Petersburg, FL