Brief Title
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
Official Title
A Phase II Trial of Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
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 cells from growing by blocking the blood supply to the tumor.
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% 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Response Rate
Secondary Outcome
16-Week Progression-Free Survival
Condition
Ovarian Cancer
Intervention
Sunitinib
Study Arms / Comparison Groups
Sunitinib
Description: Patients received oral Sunitinib at the daily dose of 37.5 mg continuously over a 28- day treatment cycle. Treatment continued until clinical or radiological evidence of progressive disease or excessive toxicity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
36
Start Date
September 2008
Completion Date
February 2013
Primary Completion Date
May 2012
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Susana M. Campos, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00768144
Organization ID
08-056
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Beth Israel Deaconess Medical Center
Study Sponsor
Susana M. Campos, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
July 2018