Vitamin D, Leptin, Vitamin D Receptor Polymorphism, and Treatment-Related Morbidity in Ovarian Cancer

This study will contain 2 cohorts: those with normal serum 25(OH)D and those with low serum
25(OH)D at enrollment. The study will take place in women with ovarian, primary peritoneal,
and fallopian tube cancer.

Patients who have given written consent to enroll in the study will have a serum 25(OH)D
levels, serum leptin levels, and vitamin D receptor FokI single nucleotide polymorphism
analyzed at the time of diagnosis. Patients with vitamin D deficiency will be prescribed
vitamin D supplementation according to current guidelines. Treatment with cholecalciferol
will not impact cancer therapy. Participants treatment course information will be collected
prospectively, but will not be dictated by this study. Serum 25(OH)D and leptin levels will
be collected again at the completion of primary therapy, 6 months after the completion of
primary therapy, and at the time of disease recurrence. If patients remain vitamin D
deficient at any of these follow-up time points, they will be referred to an endocrinologist
for further work-up and treatment of their vitamin D deficiency. Data collection will
continue for up to 1 year after enrollment.

Inclusion Criteria:

- Patients must have a histologic diagnosis of ovarian, fallopian tube, or primary
peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional
radiology, paracentesis, or CT guided core biopsy. Histologic documentation of the
original primary tumor is required via the pathology report.

- Patients must have adequate: Renal function: Glomerular Filtration Rate (GFR) > 30;
Gastrointestinal absorption: No underlying malabsorption syndrome (i.e. inflammatory
bowel disease, celiac disease)

- Ability to tolerate oral medication

- Patients taking vitamin D at the time of enrollment without a diagnosis of vitamin D
deficiency

- Patients of childbearing potential must have a negative pregnancy test prior to the
study entry and be practicing an effective form of contraception.

- If applicable, patients must discontinue breastfeeding prior to study entry.

- Patients must be at least 18 years old

Exclusion Criteria:

- Patients with a known pre-existing diagnosis of vitamin D deficiency.

- Patients with renal disease and a GFR <30

- Patients with primary hyperparathyroidism

- Patients with other invasive malignancies, with the exception of nonmelanoma skin
cancer.

- Patients with concomitant endometrial cancer diagnosed at the time of their ovarian
cancer are allowed to participate if the endometrial cancer is International
Federation of Gynecology and Obstetrics stage 1B or less.

- Patients of childbearing potential, not practicing adequate contraception, patients
who are pregnant, or patients who are breastfeeding are not eligible for this trial.