This phase II trial studies the side effects of sunitinib malate and how well it works in treating patients with ovarian cancer that is persistent or has come back. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PRIMARY OBJECTIVES: I. To evaluate the anti-tumor activity of SU11248 (sunitinib malate), a highly potent, selective tyrosine kinases inhibitor, in patients with persistent or recurrent clear cell ovarian carcinoma. II. To examine the nature and degree of toxicity in this cohort of patients treated with this regimen. SECONDARY OBJECTIVES: I. To characterize the distribution of progression-free survival and overall survival for patients treated with SU11248 (sunitinib malate). TERTIARY OBJECTIVES: I. To determine the pre-cycle 1, pre-cycle 4 and off-treatment levels of pro-angiogenic proteins (e.g., angiogenin, soluble vascular cell adhesion molecule \[VCAM\]-I, basic fibroblast growth factor \[bFGF\], platelet-derived growth factor \[PDGF\], placental growth factor \[PlGF\], vascular endothelial growth factor \[VEGF\], and hypoxia-inducible factor \[HIF\]1alpha). II. To identify changes in serum and plasma angiogenesis markers at baseline (pre-cycle 1), during treatment (cycle 4), and at progression in association with primary and secondary clinical endpoints associated with clinical response or progression-free survival. OUTLINE: Patients receive sunitinib malate orally (PO) once daily (QD) for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Correlative studies
Given PO
Objective Tumor Response Rate (Complete and Partial Response)
Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.
The Percentage of Patients Who Survive Progression Free for at Least 6 Months
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months
Overall Survival
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time frame: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually, for a total duration of 8.25 years
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
Los Angeles County-USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
John Muir Medical Center-Walnut Creek
Walnut Creek, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
AdventHealth Orlando
Orlando, Florida, United States
...and 87 more locations
Progression-free Survival
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1
Time frame: Tumor scans were done every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter for up to 5 years.
Number of Participants With Grade 3 or Higher Adverse Events
Grade 3 or higher adverse events were graded by CTC AE v 4.
Time frame: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up.