Sunitinib Malate in Treating Patients With Persistent or Recurrent Clear Cell Ovarian Cancer
NCT ID: NCT00979992
Last Updated: 2020-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2010-04-19
2019-02-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (sunitinib malate)
Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis
Correlative studies
Sunitinib Malate
Given PO
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Sunitinib Malate
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If the primary tumor had at least 50% clear cell histomorphology, a biopsy of the recurrent or persistent tumor is not required; however, immunohistochemical studies of the primary tumor for ER and WT-1 antigens should be performed and the slides submitted to the GOG for review; the percentage of clear cell histomorphology must be documented in the pathology report or in an addendum to the original report; if slides of the primary tumor are not available for review due to disposal of slides by the histology laboratory (typically 10 years after diagnosis), biopsy of recurrent or persistent disease is required
* If the primary tumor had less than 50% clear cell histomorphology (or if slides of the primary tumor are not available for review), a biopsy of the recurrent or persistent tumor is required to confirm at least 50% clear cell histomorphology and lack of immunoreactivity for ER and WT-1 antigens by immunohistochemistry; the percentage of involvement must be documented in the pathology report or in an addendum to the original report
* All patients must have measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
* Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy; thus, a confirmed biopsy in an irradiated area at a date longer than 90 days post-completion of radiation can be considered a target lesion to assess progression and response
* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
* Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease according to the following definition:
* Cytotoxic regimens include any agent that targets the genetic and/or mitotic apparatus of dividing cells, resulting in dose-limiting toxicity to the bone marrow and/or gastrointestinal mucosa
* Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease) must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy
* Patients may have received prior biologic therapy, but must not have had any prior therapy with agents which inhibit VEGF, vascular endothelial growth factor receptor (VEGFR) or PDGF such as, bevacizumab, sorafenib, sunitinib, pazopanib, brivanib, aflibercept cediranib, BIBF 1120, imatinib, dasatinib
* Any other prior therapy directed at the malignant tumor, including immunologic agents (e.g. tamoxifen) must be discontinued at least three weeks prior to registration
* Patients must not be eligible for a higher priority (e.g.; Phase III), GOG protocol for the same population if one exists
* Patients must be recovered from effects of recent surgery (28 days must elapse between surgery and the start of treatment with sunitinib malate)
* Patents must have \>= 4 weeks since prior chemotherapy or radiation (\>= 6 weeks for nitrosoureas or mitomycin C)
* Sunitinib metabolizes via liver enzyme, specifically the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme; therefore, potential drug interaction with the CYP3A4 enzyme can occur; eligible patients who are on the CYP3A4 inducer or inhibitor enzyme should stop 2 weeks prior to study entry if all other eligibility has been confirmed; the principal investigator will review the case and make all effort to switch such agent to other medication
* Patients should be free of active infection (with the exception of uncomplicated urinary tract infections \[UTI\]) requiring antibiotics
* Patients who have received one prior regimen must have a GOG performance status of 0, 1 or 2; patients who have received two prior regimens must have GOG performance status of 0 or 1
* Absolute neutrophil count (ANC) \>= 1,500/mcl
* Platelets greater than or equal 100,000/mcl
* Creatinine less than or equal to 1.5 times the upper limit of normal (ULN)
* Bilirubin less than or equal to 1.5 ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times the ULN, unless subjects have liver metastasis, in which case both AST and ALT must be less than or equal to 5 times the ULN
* Patients who have met the pre-entry requirements
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria
* Patients with serious non-healing wound, ulcer, or bone fracture
* Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
* Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6months of the first date of treatment on this study
* Patients with clinically significant cardiovascular disease; this includes:
* Poorly controlled hypertension (systolic blood pressure of \>= 140 mm Hg or diastolic blood pressure of \>= 90 mm Hg) are ineligible
* Myocardial infarction or unstable angina within 6 months prior to registration
* New York Heart Association (NYHA) grade II or greater congestive heart failure
* Cardiac arrhythmia requiring medication
* Grade II or greater peripheral vascular disease based on National Cancer Institute Common Terminology Criteria (NCI CTC); e.g. ischemic rest pain, minor tissue loss, and ulceration or gangrene
* Patients with QTc prolongation (\> 500 msec) are excluded
* Patients who require use of therapeutic doses of Coumadin-derivative anticoagulants such as warfarin are ineligible, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; low molecular weight heparin is permitted provided patient's prothrombin time (PT) international normalized ratio (INR) is =\< 1.5
* Patients with clinically significant peripheral artery disease, e.g., those with claudication, within 6 months
* Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible; patients with a history of hypothyroidism are eligible provided they are currently euthyroid
* Patients whose circumstances do not permit completion of the study or the required follow-up
* Patients who are pregnant or nursing; to date, no fetal studies in animals or humans have been performed; the possibility of harm to a fetus is likely; this drug specifically inhibits VEGF, which is responsible for formation of new blood vessels during development, and antibodies can cross the placenta; therefore, it should not be administered to pregnant women; subjects will be apprised of the large potential risk to a developing fetus; it is not known whether the drug is excreted in human milk; because many drugs are excreted in human milk, this drug should not be administered to nursing women; women of childbearing potential must agree to use contraceptive measures during study therapy and for at least 3 months after completion of therapy; a negative serum pregnancy test within 72 hours of starting drug is required
* Patients who have a major surgical procedure, or significant traumatic injury within 28 days prior to the first date of treatment on this study, or anticipation of need for major surgical procedure during the course of the study; patients with placement of vascular access device or core biopsy within 7 days prior to the first date of treatment on this study
* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy
* Patients who have received prior therapy with this drug
18 Years
FEMALE
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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John K Chan
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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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
Northside Hospital
Atlanta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Sudarshan K Sharma MD Limited-Gynecologic Oncology
Hinsdale, Illinois, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
McFarland Clinic PC - Ames
Ames, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Lakeland Hospital Niles
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Center of Hope at Renown Medical Center
Reno, Nevada, United States
Renown Regional Medical Center
Reno, Nevada, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
Parkland Memorial Hospital
Dallas, Texas, United States
Clements University Hospital
Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Keimyung University-Dongsan Medical Center
Jung-Ku, Daegu, South Korea
Samsung Medical Center
Seoul, Korea, South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Countries
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References
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Chan JK, Brady W, Monk BJ, Brown J, Shahin MS, Rose PG, Kim JH, Secord AA, Walker JL, Gershenson DM. A phase II evaluation of sunitinib in the treatment of persistent or recurrent clear cell ovarian carcinoma: An NRG Oncology/Gynecologic Oncology Group Study (GOG-254). Gynecol Oncol. 2018 Aug;150(2):247-252. doi: 10.1016/j.ygyno.2018.05.029. Epub 2018 Jun 18.
Other Identifiers
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NCI-2011-03811
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000654556
Identifier Type: -
Identifier Source: secondary_id
GOG-0254
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0254
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-03811
Identifier Type: -
Identifier Source: org_study_id
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