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GOG 0264: Ovarian Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if treatment for ovarian cancer with paclitaxel + carboplatin (investigational chemotherapy) works as well and with fewer side effects than the standard chemotherapy option (bleomycin + etoposide + cisplatin (BEP).
We are also interested to find out if a blood test could let us know about your treatment response.

What is the Condition Being Studied?

Ovarian stromal cancer either newly diagnosed or known diagnosis without any chemotherapy

Who Can Participate in the Study?

Adults who
- Have a new diagnosis of advanced stage stromal ovarian cancer
- Have been diagnosed with ovarian cancer within the past 8 weeks and have not had chemotherapy
- Are not pregnant or breastfeeding

Age Group
Adults

What is Involved?

If you agree to be in the study, you will:
- Be randomized (put into one of two groups by chance like the flip of a coin) to receive investigational or standard chemotherapy
- Be given either paclitaxel + carboplatin (the investigational therapy) through an IV for up to 4 hours every 21 days for 18 weeks (6 cycles)
OR
- One dose of bleomycin every 3 weeks + etoposide and cisplatin each daily for 5 days every 3 weeks through an IV for a total of 12 weeks (4 cycles) (the standard therapy)
- Have a blood test before and during your treatment period
- Have a chest x-ray and breathing test to look at your lung function
- Be followed for 3-6 months for the first 5 years, then every year after you've completed treatment

Study Details

Full Title
GOG 0264: A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of The Ovary
Principal Investigator
Gynecologic Cancers Specialist
Protocol Number
IRB:PRO00022731
NCT:NCT01042522
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698