Ovarian Cancer Clinical Trial
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
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.
Full Description
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.
Eligibility 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
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There are 3 Locations for this study
Boston Massachusetts, 02115, United States
Boston Massachusetts, 02214, United States
Boston Massachusetts, 02215, United States
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