Gynecologic Cancer GOG 281

April 26, 2017

Sponsor: National Cancer Institute (NCI)

Number: GOG 281

Eligible patients who enroll in the study will be randomly assigned (by chance) to this phase II/III trial that studies how well Trametinib works and compares it to standard treatment with either Letrozole, Tamoxifen citrate, Paclitaxel, Pegylated Liposomal Doxorubicin Hydrochloride, or Topotecan hydrochloride in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back, become worse, or spread to other parts of the body. Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety. Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal (lining of the abdomen) cavity cancer.

Who’s eligible:

• Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I  serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg). In Grade 1 tumors, the tumor cells and the organization of the tumor tissue appear close to normal.
• Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur (come back) as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
• At least 4 weeks must have elapsed since the patient underwent any major surgery (eg. MAJOR: laparotomy, laparoscopy, thoracotomy, VATS [video assisted thorascopic surgery]. There is no restriction on MINOR procedures: (eg. central venous catheter placement, ureteral stent placement or exchange, tumor core or fine-needle aspirate [FNA] biopsy).
• Patients must have documented low-grade serous carcinoma (slow-growing cancer that is generally resistant to cytotoxic chemotherapy). Confirmation must occur by prospective pathology review prior to study entry. The prospective pathology review can be done on tissue from the recurrent carcinoma or from original diagnostic specimen.
• This study is for women 18 or older.

Available at: Hartford Hospital.