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Number: GOG 0212 Principal Investigator: Mutch, David
Title: A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or XYOTAX, Versus No Treatment Until Documented Relapse in Women with Advanced Ovarian or Primary Peritoneal Cancer Achieve A Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Phase: III Disease Site: Multiple Sites
Participating Site(s):
 
Main Campus
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Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
Primary peritoneal and fallopian tube cancers are considered identical to ovarian cancers in terms of microscopic appearance and treatment; they differ only by the initial body site of cancer development. A previously completed study showed that women with advanced ovarian cancer who had no sign of active disease after the completion of the initial 5 or 6 cycles of chemotherapy who continued to receive chemotherapy had a delay in the return of their cancer. Unfortunately, in this trial it was not possible to determine if the delay in the return of their cancer was associated with an improvement in how long they lived. A second question that was not answered by this completed study was whether the benefit of the delay in the return in cancer was outweighed by the side effects of continuing the chemotherapy.

In the current trial we wish to examine whether women with advanced ovarian, primary peritoneal or fallopian tube 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 recurrence of the disease process. Two different chemotherapy regimens and one regimen including no further treatment will be examined.

The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer, and was the agent utilized in the trial noted above. The second agent CT-2103, is an experimental drug (drug not approved by the Food and Drug Administration) with anti-cancer activity similar to that of paclitaxel. It is possible that CT-2103 will produce similar results to that achieved with paclitaxel, but with reduced side effects. The third arm of the study is to receive no further treatment after the completion of initial chemotherapy, if there is no evidence of disease. You have an equal chance of being placed in any one of the three regimens. Neither you nor your doctor will decide which regimen you receive.

This study is also interested in testing samples of your blood and some of your tumor if available from a previous biopsy or surgery. The purpose of this research is to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.
 
More Information:
Internal Protocol Documents (requires Siteman administrative database password)