Status:
COMPLETED
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ce...
Detailed 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%...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00768144
Start Date
September 1 2008
End Date
February 1 2013
Last Update
August 24 2018
Active Locations (3)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
3
Beth-Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215