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Therapeutic Areas: Oncology
Disease Category: Peritoneal Cancer
Trial Information
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
Rudy Segna, MD, Principal Investigator
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Phone: 212-888-8439
Fax: 212-319-1140
EMail: rudy.segna@mssm.edu
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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