Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma

This study used a two-stage design to evaluate efficacy of sunitinib based on overall
response (OR) defined as complete response (CR) or partial response (PR). The null and
alternative OR rate were 5% and 20%. If one or more patients enrolled in the stage one cohort
(n=17 patients) achieved PR or better than accrual would proceed to stage two (n=18
patients). There was 42% probability of stopping the trial at stage one if the true OR rate
was 5%. With 35 patients, this design had 85% power to detect the 15% difference in OR rates
assuming 2-sided type I error rate of 0.05.

Inclusion Criteria:

- Histologically or cytologically confirmed epithelial ovarian, fallopian tube or
peritoneal cancer

- Recurrent or refractory disease

- Measurable disease, defined by RECIST

- 0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease

- Adverse events related to prior tumor-specific therapy must have resolved to less than
or equal to grade 1 prior to study entry

- Ability to swallow oral medications

- 18 years of age or older

- ECOG Performance status must be 0-2

- Normal organ and marrow function as outlined in the protocol

Exclusion Criteria:

- Receiving systemic therapy less than 14 days prior to starting sunitinib

- Receiving any other investigational agent

- Received prior sunitinib

- Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain
metastases or leptomeningeal disease as noted on screening CT or MRI scans

- Any of the following within the 6 months prior to study drug administration:
myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
graft, symptomatic congestive heart failure, cerebrovascular accident or transient
ischemic attack, or pulmonary embolism.

- Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse
hemorrhage within 4 weeks of starting study treatment

- Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade > 2

- Pre-existing thyroid abnormality, with thyroid function tests that cannot be
maintained in the normal range with medication

- Prolonged QTc interval on baseline EKG

- Uncontrolled hypertension

- Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin,
theophylline, ketoconazole, or St. John's wort.

- Psychiatric illness or social situations that wold limit compliance with study
requirements

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration

- Pregnant women

- Clinical or radiographical evidence of a small bowel obstruction

- Poor oral intake