Clinical trial NCT00768144: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: Sutent
sunitinib
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
name: Massachusetts General Hospital
First posted: 2008-10-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Response Rate
timeFrame: Clinical assessments were performed weekly for first 4 weeks and every 2 wks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of trt.
Secondary outcomes:
measure: 16-Week Progression-Free Survival
timeFrame: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
measure: Progression-Free Survival
timeFrame: Clinical assessments were performed weekly for first 4 weeks and every 2 weeks in subsequent cycles. Disease was evaluated radiologically at baseline, before each odd cycle and at end of treatment.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth-Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Susana M. Campos, MD
role: PRINCIPAL_INVESTIGATOR
References: