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
Johns Hopkins Kimmel Cancer Center in Baltimore
- To estimate the progression-free survival of the combination of weekly gemcitabine and pazopanib compared to weekly gemcitabine alone in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer - To obtain preliminary estimates of overall survival, time to progression and the duration of response in this patient population - To determine the frequency and severity of side effects
- recurrent or persistent ovarian, fallopian tube or primary peritoneal cancer - measurable or detectable disease - good performance status and lab values - must have had one prior platinum based chemotherapy for primary disease - allowed to receive 2 additional chemotherapy regimens - no prior pazopanib or weekly gemcitabine
This is an outpatient regimen. Patients will be randomized to receive one of two Regimens. Both Regimens will receive Gemcitabine will be administered IV over 30 minutes on Days 1 and 8 of a 21 day cycle. Regimen II will receive Pazopanib orally for 21 days in addition to the Gemcitabine. Treament may continue until disease progression or unacceptable toxicity.
05/24/2016 05:03 AM