Protocol: NRG – GY019

Schema – GY019

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

1. Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube
   and primary peritoneal cancers. p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (aberrant p53 expression is consistent with mutant TP53 and supports diagnosis of high grade serous ovarian cancer).
2. History/physical examination within 14 days prior to registration.
3. Contrast-enhanced Imaging of the chest, abdomen and pelvis within 28 days prior to registration.
4. Age ≥ 18.
5. Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (<=1cm diameter residual disease/nodule) or suboptimal residual disease (>1 cm diameter residual disease/nodule) status allowed.
6. Patients must have undergone a bilateral salpingo-oophorectomy.
7. ECOG Performance Status of 0, 1 or 2.
8. Patients must be able to take per oral (P.O.) medications.
9. Patients must be within ≤8 weeks of primary cytoreductive surgery at time of randomization.

Ineligibility:

1. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the
   investigational regimen are eligible for this trial.
2. Patients may not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
3. Patients may not have received previous hormonal therapy for the treatment of this disease.
4. Patients with ≥grade 2 baseline neuropathy.
5. Patients with active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection.