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

Completed · Phase 2

Conditions studied: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

In brief

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.

Key facts

Study ID

NCT00768144

Run by

Dana-Farber Cancer Institute

People needed

36

Starts

2008-09-01

Expected to finish

2013-02-01

Last updated by the study team

2018-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth-Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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