A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or 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: GOG-212
Standard chemotherapy is effective in controlling the growth and spread of ovarian, primary peritoneal, and fallopian tube cancer, but a long term cure is uncommon through chemotherapy.
The purpose of this study is to examine whether women with this type of cancer, who have no evidence of disease after 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. Two different chemotherapy regimens (Arm 1: standard chemotherapy drug, Arm 2: CT-2103) will be examined, including 1 regimen in which no further treatment will occur.
This study is also interested in testing samples of your blood and tumor tissue. 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.
Participants and/or their insurance provider will be responsible for some or all of the costs of treating their cancer. CT-2103 will be supplied to participants free of charge by the manufacturer.
In general, this study is looking for participants who:
- Are aged 18 years or older.
- Is NOT pregnant.
- Have a diagnosis of primary peritoneal carcinoma or epithelial ovarian carcinoma, Stage III or IV, with either optimal or sub-optimal residual disease following initial surgery.
- Have had surgery for ovarian or peritoneal carcinoma with tissue available for histologic evaluation to confirm diagnosis and stage.
- Have completed treatment within the past 12 weeks with at least 5 cycles, and more than 8 cycles, of a platinum and Paclitaxel or Docetaxel- based combination chemotherapy.
- Has NO symptoms suggestive of persistent cancer, a normal CT scan and normal CA-125 levels following chemotherapy treatment.
- Has adequate: Bone marrow, Renal, Hepatic, and Neurologic function.
- Does NOT have an active infection requiring antibiotics.
Janet L. Osborne, M.D.
Carilion GYN Oncology Associates