Ovarian Cancer Clinical Trial
Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer
Summary
This phase II trial studies how well dasatinib works in treating patients with ovarian, fallopian tube, endometrial, or peritoneal cancer that has come back or is persistent. Dasatinib may shrink patients' tumors by blocking some of the enzymes needed for cell growth.
Full Description
PRIMARY OBJECTIVES:
I. To assess the clinical activity of dasatinib in patients with recurrent or persistent ovarian, fallopian tube, primary peritoneal, and endometrial clear cell carcinoma using objective tumor response (complete and partial): in patients without loss of BRG-associated factor 250a (BAF250a) expression and in patients with loss of BAF250a expression.
SECONDARY OBJECTIVES:
I. To examine the nature and degree of toxicity in this patient population treated with this regimen in patients with and without loss of BAF250a expression.
II. To examine the progression-free survival and overall survival for this patient population receiving dasatinib in patients with and without loss of BAF250a expression.
TERTIARY OBJECTIVES:
I. To examine the agreement between BAF250a immunohistochemistry and AT rich interactive domain 1A (SWI-like) (ARID1A) mutation status using next generation sequencing performed in formalin-fixed, paraffin-embedded tumor tissue.
OUTLINE:
Patients receive dasatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days 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.
Eligibility Criteria
Inclusion Criteria:
Patients must have recurrent or persistent ovarian, fallopian tube, peritoneum, and endometrial clear cell carcinoma; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; in addition, the tumors should be negative for expression of Wilms tumor 1 (WT-1) antigen (with the exception of endometrial cancers where WT-1 stains are not required) and estrogen receptor (ER) antigen by immunohistochemistry; focal, weak, ER staining of tumor cells (< 5%) is permitted; appropriate tissue sections must be available for histologic evaluation for central pathology review by Gynecologic Oncology Group (GOG); immunohistochemical stained slides for ER and WT-1 antigen must be available for review by GOG
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 immuno-reactivity 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
Patients must have results from the determination of BAF250a immunohistochemistry (IHC) status and must have a BAF250a expression status that is currently open to enrollment
All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 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 had one prior platinum-based chemotherapeutic regimen for management of primary disease; patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease
Patients must be >= 3 weeks from last chemotherapy or radiation (6 weeks for nitrosoureas or mitomycin)
Patients must have progressed on, be ineligible for, or have declined participation in GOG-0254 provided that protocol is actively accruing patients
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Creatinine =< 1.5 times the upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min/1.73 m^2
Bilirubin =< 1.5 ULN
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase ALT (serum glutamate pyruvate transaminase [SGPT]) =< 3 x ULN
Patients who are on concomitant medications that are STRONG inducers or inhibitors of the cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) enzyme should stop 2 weeks prior to first dose of dasatinib, if all other eligibility has been confirmed
Corrected QT (QTc) interval on electrocardiogram must be =< 480 msec (Fridericia correction)
Patients who have received one prior regimen must have a GOG performance status of 0, 1 or 2; patients who have received two or more prior regimens must have GOG performance status of 0 or 1
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:
Prior treatment with dasatinib, imatinib or nilotinib
Patients with symptomatic effusions (pleural, pericardial, or peritoneal) and/or those who have required a procedure for symptomatic effusions within 4 weeks of start of dasatinib are ineligible
Patients with a history of cardiac disease including: (1) uncontrolled angina, congestive heart failure, or myocardial infarction within six months prior to study entry, (2) congenital long QT syndrome, (3) clinical significant ventricular arrhythmias
The concomitant use of histamine (H)2 blockers and proton pump inhibitors (PPIs) with dasatinib is not recommended; the use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy; if antacid therapy is needed, the antacid dose should be administered two hours before or after the dose of dasatinib; patients who cannot tolerate discontinuation of H2 blockers or PPIs are ineligible
Therapeutic anticoagulation is not contraindicated, but for those patients on therapeutic anticoagulation, alteration in coagulation parameters is expected following initiation of dasatinib; for patients on therapeutic anticoagulation, coagulation parameters should be assessed weekly for the first cycle following initiation of dasatinib, weekly for the first cycle following a dose reduction, and weekly for a minimum of two weeks after stopping dasatinib
Patients whose circumstances do not permit completion of the study or the required follow-up
Patients who are pregnant or nursing; women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 3 months after completion of therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; 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
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
Patients who are unable to swallow pills
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There are 187 Locations for this study
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Anchorage Alaska, 99508, United States
Auburn California, 95602, United States
Auburn California, 95603, United States
Berkeley California, 94704, United States
Burlingame California, 94010, United States
Cameron Park California, 95682, United States
Castro Valley California, 94546, United States
Davis California, 95616, United States
Modesto California, 95355, United States
Mountain View California, 94040, United States
Mountain View California, 94040, United States
Palo Alto California, 94301, United States
Roseville California, 95661, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
San Francisco California, 94115, United States
San Francisco California, 94115, United States
San Francisco California, 94158, United States
Santa Cruz California, 95065, United States
Santa Rosa California, 95403, United States
Sunnyvale California, 94086, United States
Vacaville California, 95687, United States
Vallejo California, 94589, United States
Hartford Connecticut, 06102, United States
Hartford Connecticut, 06105, United States
New Britain Connecticut, 06050, United States
Atlanta Georgia, 30342, United States
Cumming Georgia, 30041, United States
Gainesville Georgia, 30501, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
'Aiea Hawaii, 96701, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96813, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96817, United States
Honolulu Hawaii, 96826, United States
Lihue Hawaii, 96766, United States
Boise Idaho, 83706, United States
Boise Idaho, 83712, United States
Fruitland Idaho, 83619, United States
Meridian Idaho, 83642, United States
Nampa Idaho, 83686, United States
Twin Falls Idaho, 83301, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carbondale Illinois, 62902, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Chicago Illinois, 60637, United States
Danville Illinois, 61832, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Effingham Illinois, 62401, United States
Effingham Illinois, 62401, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Hinsdale Illinois, 60521, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Mattoon Illinois, 61938, United States
Mount Vernon Illinois, 62864, United States
New Lenox Illinois, 60451, United States
O'Fallon Illinois, 62269, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46260, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50316, United States
West Des Moines Iowa, 50266, United States
Scarborough Maine, 04074, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Minneapolis Minnesota, 55454, United States
New Ulm Minnesota, 56073, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Bonne Terre Missouri, 63628, United States
Branson Missouri, 65616, United States
Cape Girardeau Missouri, 63703, United States
Cape Girardeau Missouri, 63703, United States
Jefferson City Missouri, 65109, United States
Rolla Missouri, 65401, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63131, United States
Saint Louis Missouri, 63141, United States
Sainte Genevieve Missouri, 63670, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65804, United States
Springfield Missouri, 65807, United States
Sullivan Missouri, 63080, United States
Sunset Hills Missouri, 63127, United States
Omaha Nebraska, 68114, United States
Carson City Nevada, 89703, United States
Las Vegas Nevada, 89106, United States
Reno Nevada, 89502, United States
Reno Nevada, 89502, United States
Basking Ridge New Jersey, 07920, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Sleepy Hollow New York, 10591, United States
Uniondale New York, 11553, United States
Hendersonville North Carolina, 28792, United States
Winston-Salem North Carolina, 27104, United States
Belpre Ohio, 45714, United States
Chillicothe Ohio, 45601, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43213, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43214, United States
Columbus Ohio, 43215, United States
Columbus Ohio, 43219, United States
Columbus Ohio, 43222, United States
Columbus Ohio, 43228, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Delaware Ohio, 43015, United States
Lancaster Ohio, 43130, United States
Mansfield Ohio, 44903, United States
Marietta Ohio, 45750, United States
Marion Ohio, 43302, United States
Mayfield Heights Ohio, 44124, United States
Mentor Ohio, 44060, United States
Mount Vernon Ohio, 43050, United States
Newark Ohio, 43055, United States
Newark Ohio, 43055, United States
Portsmouth Ohio, 45662, United States
Springfield Ohio, 45505, United States
Westerville Ohio, 43081, United States
Zanesville Ohio, 43701, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Abington Pennsylvania, 19001, United States
Providence Rhode Island, 02905, United States
Anderson South Carolina, 29621, United States
Gaffney South Carolina, 29341, United States
Greenville South Carolina, 29601, United States
Greer South Carolina, 29651, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57701, United States
Rapid City South Dakota, 57701, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Burlington Wisconsin, 53105, United States
Fond Du Lac Wisconsin, 54937, United States
Germantown Wisconsin, 53022, United States
Grafton Wisconsin, 53024, United States
Green Bay Wisconsin, 54311, United States
Kenosha Wisconsin, 53142, United States
Marinette Wisconsin, 54143, United States
Milwaukee Wisconsin, 53209, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53233, United States
New Richmond Wisconsin, 54017, United States
Oshkosh Wisconsin, 54904, United States
Racine Wisconsin, 53406, United States
Sheboygan Wisconsin, 53081, United States
Summit Wisconsin, 53066, United States
Two Rivers Wisconsin, 54241, United States
Waukesha Wisconsin, 53188, United States
Wauwatosa Wisconsin, 53226, United States
West Allis Wisconsin, 53227, United States
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