Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Trial Description:

This study is trying to find out if a medicine called letrozole, given with or without two chemotherapy drugs, paclitaxel and carboplatin, works better to treat people with stage II-IV low-grade serous carcinoma, a type of cancer in the ovary, fallopian tube, or peritoneum. Letrozole lowers the amount of estrogen in the body, which can help stop cancer cells from growing if they need estrogen. Paclitaxel and carboplatin are chemotherapy drugs that either kill cancer cells, stop them from growing, or keep them from spreading. The study wants to see if letrozole alone or combined with these chemotherapy drugs works better than just using the chemotherapy drugs alone.

Eligibility Requirements:

Inclusion Criteria:

1. Must have newly diagnosed stage II-IV low-grade serous ovarian cancer, which includes ovarian, fallopian tube, or primary peritoneal cancers.
2. Patients with a history of serous borderline tumors but now have stage II-IV low-grade serous ovarian cancer can join.
3. A specific test called p53 immunohistochemistry (IHC) must show a normal pattern (wildtype TP53).
-Must submit a pathology report confirming low-grade serous ovarian cancer and normal p53 results.
4. Must have completed a history and physical exam within 14 days before joining the study.
5. Must have completed a tumor assessment (such as a scan) within 28 days before joining.
6. Must be 18 years or older.
7. Must have undergone surgery to remove as much cancer as possible (cytoreductive surgery).
8. Must have had a surgery called bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes).
9. Must be in good enough health to participate (ECOG performance status 0, 1, or 2).
10. Must join the study within 8 weeks of their surgery.
11. Must be able to take medicine by mouth.
12. Must have a white blood cell count (ANC) of at least 1,500/mcl.
13. Must have a platelet count of at least 100,000/mcl.
14. Kidney function (creatinine) must be within a certain limit.
15. Liver function (bilirubin, ALT, AST) must be within a certain limit.
16. Must provide consent and agree to participate in the study.
17. Patients with other cancers can join if their other cancer doesn’t interfere with the study.

Exclusion Criteria:

1. Cannot have received chemotherapy or radiation therapy for this disease before.
2. Cannot have received hormonal therapy for this disease before.
3. Cannot have an allergy or intolerance to letrozole, carboplatin, or paclitaxel.
4. Cannot have severe heart problems, including:
5. Heart attack or unstable angina within the last 6 months.
6. Heart failure classified as NYHA class II or higher.
7. Cannot have known cancer spread to the brain or central nervous system.
8. Cannot have an active or uncontrolled infection (except a simple urinary tract infection).
9. Cannot have a neuropathy (nerve problem) at grade 2 or higher.
10. HIV-positive patients can join if they are on treatment with an undetectable viral load for at least 6 months.