Women with Ovarian or Peritoneal Cancer Sought for Research Study.


12615

A Randomized Phase III trial of Maintenance Chemotherapy Comparing 12, Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND #70177) Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal Cancer Who Achieve A Complete Clinical Response to Primary Platinum/Taxane Chemotherapy.

Obstetrics & Gynecology

Modesitt Susan, C

UVa Health System, Cancer Center seeks participants with ovarian or peritoneal primary cancer for a research study. The purpose of this study is is to compare a new chemotherapy combination of carboplatin, paclitaxel and Bevacizumab to the standard combination of carboplatin and paclitaxel alone. If you should decide to participate in the trial, you would be placed randomly into one of the three groups described below. Neither your nor the doctor choose the group nor know which treatment you are receiving. You have an equal chance of being placed in any of the three groups, below. Participants in group 1 will be treated once every three weeks with the combination of chemotherapy drugs paclitaxel and carboplatin for 6 total treatments. They will also receive placebo (intravenous fluid without Bevacizumab) by vein with chemotherapy for 5 total treatments, beginning with the second chemotherapy treatment, followed by receiving placebo intravenously every three weeks to complete a total treatment time of 15 months. Participants in group 2 will be treated once every three weeks with the combination of chemotherapy drugs paclitaxel and carboplatin for 6 total treatments. They will also receive Bevacizumab intravenously for 5 total treatments, beginning with the second chemotherapy treatment, followed by placebo intravenously every three weeks to complete a total treatment time of 15 months. Participants in group 3 will be treated once every three weeks with the combination of chemotherapy drugs paclitaxel and carboplatin for 6 total treatments. They will also receive Bevacizumab intravenously for 5 total treatments, beginning with the second chemotherapy treatment, followed by treatment with Bevacizumab intravenously every three weeks to complete a total treatment time of 15 months. Following the fifteen-month treatment time described above, participants will undergo blood tests, scans, and office visits every three months for a total of 24 months, then every 6 months thereafter. There will be no financial compensation for this study. Contact Information: For more information please contact: Heather Lothamer, MSN, CCRC (434)924-2745 or hll5y@virginia.edu IRB-HSR #12615 Principal Investigator: Susan Modesitt, MD


Adult

Ovarian Cancer
Vaginal/Vulval Cancer

Obstetrics/Gynecology
Cancer (Oncology)

Ill

No Compensation

Heather Lothamer

hll5y@virginia.edu

4349249924