Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

PRIMARY OBJECTIVES:

I. Evaluate response of platinum-resistant ovarian cancer to stereotactic body radiation
therapy (SBRT) using fludeoxyglucose F 18 (18F-FDG) positron emission tomography
(PET)/computed tomography (CT) 3 months after therapy.

II. Determine the rate of grade 3 or greater non-hematologic acute toxicity from SBRT using
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

SECONDARY OBJECTIVES:

I. Evaluate response to SBRT using cancer antigen-125 (CA-125) and symptom assessment using
Functional Assessment of Cancer Therapy (FACT)-Ovarian Symptom Index (FOSI).

II. Determine the rate of late and non-grade 3 acute toxicity using CTCAE version 4.0.

III. Evaluate local control, progression-free survival, and overall survival following SBRT.

OUTLINE:

Patients undergo SBRT 5 days a week for approximately 1 week in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 6 weeks, 3, 6, 9, and 12
months, and then every 6 months for 4 years.

Inclusion Criteria:

- Patients must have persistent, metastatic, or recurrent platinum resistant or
refractory ovarian or primary peritoneal cancer.

- No restriction on previous treatment regimens, but patients must be at least 2 weeks
out from last chemotherapy or investigational agent.

- Patients must be >= 18.

- Patients must have a life expectancy of at least 6 months.

- Patients must have KPS >= 60.

- Patients must have acceptable organ and marrow function as defined below (within 2
weeks prior to radiotherapy):

- leukocytes >=3,000/uL

- absolute neutrophil count >=1,500uL

- platelets >=100,000/uL

- total bilirubin within 1.5X normal institutional limits

- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

- creatinine within normal institutional limits OR

- creatinine clearance >=60 mL/min/1.73 m^2 for patients with creatinine levels
above institutional normal

- Patients must be willing to undergo a pre- and post-treatment FDG-PET/CT.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Patients should not have received radiation overlapping with the proposed treatment
field.

- Patients cannot be receiving chemotherapy or other investigation agents from two
weeks prior to radiation through undergoing their post-therapy FDG-PET/CT

- Patients cannot be pregnant or nursing.

- Patients cannot have disease >= 8cm or greater than 3 regions of disease.

- Patients cannot have concurrent malignancy other than non-melanoma skin cancer,
non-invasive bladder cancer, or carcinoma in situ of the cervix.