Trial Information

Summary: 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 Official Response to Primary Platinum/Taxane Chemotherapy [GOG0212]

This is a research study for women who have ovarian or primary peritoneal cancer that has been confirmed by surgery and you have completed your initial standard chemotherapy. The purpose of this study is to examine whether women with advanced ovarian cancer who have no evidence of disease after the completion of initial chemotherapy live longer if a specific treatment program is continued once a month for 12 months, versus stopping all chemotherapy until there is evidence of return of the disease.
Study participants have an equal chance of being placed into one of the following of 3 groups:
1. Paclitaxel (Taxol) is a standard chemotherapy drug used to treat ovarian cancer.
2. Xyotax is an experimental drug with anti-cancer activity similar to that of paclitaxel.
3. The third group does not involve any treatment.

No Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible to participate if you
-are 18 years of age or older
-have been diagnosed with ovarian or primary peritoneal cancer that has been confirmed by surgery
-have completed your initial standard chemotherapy

You will not be eligible to participate if you
-have chronic hepatitis
-have ongoing gastrointestinal bleeding requiring blood product support
-have received prior radiotherapy to any portion of the abdominal cavity or pelvis

If you would like to learn more about participating in this study, please send an e-mail message using the form below.