GOG 0212: Ovarian, Peritoneal or Fallopian Tube Cancer
GOG 0212: 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, Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy
Approval Date: 12/31/1969
Principal Investigator: SHELDON WEINER, MD
Your physician has informed you that you need chemotherapy to control the growth of your tumor and reduce the chance of recurrence. Standard chemotherapy for your cancer is effective, but a long-term cure is uncommon. Many patients will eventually develop recurrent disease and need additional treatment. It is hoped that new chemotherapy combinations may improve on the success achieved with current standard treatment programs. 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. 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 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.
Patients with diagnosis of primary peritoneal carcinoma, or Stage III-IV epithelial ovarian or fallopian tube carcinoma, with either optimal (≤ 1 cm residual disease) or suboptimal residual disease following initial surgery.
Had appropriate surgery for ovarian, primary peritoneal or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
Patients must have completed treatment within the past 12 weeks with at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy and have no symptoms suggestive of persistent cancer
Patients must have received at least two cycles after interval abdominal surgery.
Status of Clinical Trial:
open and enrolling