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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of sunitinib on participants with ovarian, fallopian tube or peritoneal cancer. Sunitinib is a newly discovered drug that may stop cancer cells from growing by blocking the blood supply to the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Sunitinib

Criteria

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