Title (GOG 212) 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
Principal Investigator Adekunle Odunsi, MD PhD
Study Number 64705
Summary This study is for patients with ovarian, primary peritoneal, or fallopian tube cancer that has been confirmed by surgery. The patients are informed that they need chemotherapy to control the growth of their tumor and reduce the chance of recurrence. Standard chemotherapy for this type of 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 recently 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 of their cancer was outweighed by the side effects of continuing the chemotherapy.
- Patients with histological diagnosis of primary peritoneal carcinoma or epithelial ovarian or fallopian tube carcinoma, Stage III or IV, with either optimal or suboptimal residual disease following initial surgery. All patients must have had appropriate surgery for ovarian, primay peritoneal pr fallopian tube carcinoma with appropriate tissue available for histological evaluation to confirm diagnosis and stage.
- Patients with the following histological epithelial cell types are eligible: Serous adenocarcinoma, endometroid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarinoma N.O.S.
- Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low malignant potential (LMP) (Borderline carcinomas) are not eligible. Patients with a prior diagnosis of a low malignant potential tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not had received prior chemotherapy for their ovarian LMP tumor.
- Patients who are pregnant or nursing are excluded; patients who may become pregnant must be practicing an effective e method of birth control.