This phase II trial studies how well dasatinib works in treating patients with persistent
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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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 and estrogen
receptor (ER) antigen by immunohistochemistry; 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
- Five unstained formalin-fixed, paraffin-embedded (FFPE) tumor tissue slides (charged,
5 um) must be submitted to the central study laboratory (i. e., Clinical Laboratory
Improvement Amendments [CLIA]-certified immuno-pathology laboratory at Memorial
Sloan-Kettering Cancer Center) for determination of BAF250a immunohistochemistry
(IHC) status
- 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
Alaska Women's Cancer Care, Anchorage, Alaska 99508, United States
Anchorage Oncology Centre, Anchorage, Alaska 99508, United States
Katmai Oncology Group, Anchorage, Alaska 99508, United States
Providence Alaska Medical Center, Anchorage, Alaska 99508, United States
Sutter Auburn Faith Hospital, Auburn, California 95602, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California 95603, United States
Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California 94704, United States
Mills - Peninsula Hospitals, Burlingame, California 94010, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California 95682, United States
Sutter Davis Hospital, Davis, California 95616, United States
Memorial Medical Center, Modesto, California 95355, United States
Palo Alto Medical Foundation-Camino Division, Mountain View, California 94040, United States
Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California 94040, United States
Palo Alto Medical Foundation Health Care, Palo Alto, California 94301, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California 95661, United States
Sutter Roseville Medical Center, Roseville, California 95661, United States
Sutter General Hospital, Sacramento, California 95816, United States
California Pacific Medical Center-Pacific Campus, San Francisco, California 94118, United States
UCSF Medical Center-Mount Zion, San Francisco, California 94115, United States
Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California 95065, United States
Sutter Pacific Medical Foundation, Santa Rosa, California 95403, United States
Palo Atlo Medical Foundation-Sunnyvale, Sunnyvale, California 94806, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California 95687, United States
Sutter Solano Medical Center/Cancer Center, Vallejo, California 94589, United States
Hartford Hospital, Hartford, Connecticut 06102, United States
Saint Francis Hospital and Medical Center, Hartford, Connecticut 06105, United States
The Hospital of Central Connecticut, New Britain, Connecticut 06050, United States
Northside Hospital, Atlanta, Georgia 30342, United States
Northside Hospital-Forsyth, Cumming, Georgia 30041, United States
Northeast Georgia Medical Center, Gainesville, Georgia 30501, United States
Oncare Hawaii Inc-Pali Momi, Aiea, Hawaii 96701, United States
Pali Momi Medical Center, Aiea, Hawaii 96701, United States
The Cancer Center of Hawaii-Leeward, Ewa Beach, Hawaii 96706, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii 96826, United States
Kuakini Medical Center, Honolulu, Hawaii 96817, United States
Oncare Hawaii Inc-Kuakini, Honolulu, Hawaii 96817, United States
Oncare Hawaii Inc-POB II, Honolulu, Hawaii 96813, United States
OnCare Hawaii-Liliha, Honolulu, Hawaii 96817-3169, United States
Queen's Medical Center, Honolulu, Hawaii 96813, United States
Straub Clinic and Hospital, Honolulu, Hawaii 96813, United States
The Cancer Center of Hawaii-Liliha, Honolulu, Hawaii 96817, United States
University of Hawaii Cancer Center, Honolulu, Hawaii 96813, United States
Wilcox Memorial Hospital and Kauai Medical Clinic, Lihue, Hawaii 96766, United States
Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho 83706, United States
Memorial Hospital of Carbondale, Carbondale, Illinois 62902, United States
Centralia Oncology Clinic, Centralia, Illinois 62801, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois 60637, United States
Cancer Care Center of Decatur, Decatur, Illinois 62526, United States
Decatur Memorial Hospital, Decatur, Illinois 62526, United States
Crossroads Cancer Center, Effingham, Illinois 62401, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois 60521, United States
Good Samaritan Regional Health Center, Mount Vernon, Illinois 62864, United States
UC Comprehensive Cancer Center at Silver Cross, New Lennox, Illinois 60451, United States
Memorial Medical Center, Springfield, Illinois 62781, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202, United States
Saint Vincent Oncology Center, Indianapolis, Indiana 46260, United States
Iowa Lutheran Hospital, Des Moines, Iowa 50316, United States
Iowa Methodist Medical Center, Des Moines, Iowa 50309, United States
Iowa Oncology Research Association CCOP, Des Moines, Iowa 50309, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa 50309, United States
Methodist West Hospital, West Des Moines, Iowa 50266-7700, United States
Maine Medical Center- Scarborough Campus, Scarborough, Maine 04074, United States
Michigan Cancer Research Consortium CCOP, Ann Arbor, Michigan 48106, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan 48106-0995, United States
Oakwood Hospital and Medical Center, Dearborn, Michigan 48124, United States
Saint John Hospital and Medical Center, Detroit, Michigan 48236, United States
Genesys Hurley Cancer Institute, Flint, Michigan 48503, United States
Hurley Medical Center, Flint, Michigan 48502, United States
Allegiance Health, Jackson, Michigan 49201, United States
Borgess Medical Center, Kalamazoo, Michigan 49001, United States
Bronson Methodist Hospital, Kalamazoo, Michigan 49007, United States
West Michigan Cancer Center, Kalamazoo, Michigan 49007, United States
Sparrow Hospital, Lansing, Michigan 48912, United States
Saint Mary Mercy Hospital, Livonia, Michigan 48154, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan 48341, United States
Saint Joseph Mercy Port Huron, Port Huron, Michigan 48060, United States
Saint Mary's of Michigan, Saginaw, Michigan 48601, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan 48093, United States
Fairview Ridges Hospital, Burnsville, Minnesota 55337, United States
Mercy Hospital, Coon Rapids, Minnesota 55433, United States
Fairview-Southdale Hospital, Edina, Minnesota 55435, United States
Unity Hospital, Fridley, Minnesota 55432, United States
Hutchinson Area Health Care, Hutchinson, Minnesota 55350, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota 55109, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota 55109, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota 55407, United States
Health Partners Inc, Minneapolis, Minnesota 55454, United States
Hennepin County Medical Center, Minneapolis, Minnesota 55415, United States
New Ulm Medical Center, New Ulm, Minnesota 56073, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota 55422, United States
Metro-Minnesota NCI Community Oncology Research Program, Saint Louis Park, Minnesota 55416, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota 55416, United States
Regions Hospital, Saint Paul, Minnesota 55101, United States
United Hospital, Saint Paul, Minnesota 55102, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota 55379, United States
Lakeview Hospital, Stillwater, Minnesota 55082, United States
Ridgeview Medical Center, Waconia, Minnesota 55387, United States
Rice Memorial Hospital, Willmar, Minnesota 56201, United States
Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota 55125, United States
CoxHealth Cancer Center, Branson, Missouri 65616, United States
Saint Francis Medical Center, Cape Girardeau, Missouri 63703, United States
Phelps County Regional Medical Center, Rolla, Missouri 65401, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri 63141, United States
Washington University School of Medicine, Saint Louis, Missouri 63110, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri 65804, United States
CoxHealth South Hospital, Springfield, Missouri 65807, United States
Mercy Hospital Springfield, Springfield, Missouri 65804, United States
Nebraska Methodist Hospital, Omaha, Nebraska 68114, United States
Women's Cancer Center of Nevada, Las Vegas, Nevada 89169, United States
Center of Hope at Renown Medical Center, Reno, Nevada 89502, United States
Renown Regional Medical Center, Reno, Nevada 89502, United States
Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Southeast Cancer Consortium-Upstate NCORP, Winston-Salem, North Carolina 27104, United States
Case Western Reserve University, Cleveland, Ohio 44106, United States
Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio 44111, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio 44124, United States
Lake University Ireland Cancer Center, Mentor, Ohio 44060, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Tulsa Cancer Institute, Tulsa, Oklahoma 74146, United States
Abington Memorial Hospital, Abington, Pennsylvania 19001, United States
Women and Infants Hospital, Providence, Rhode Island 02905, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina 29651, United States
Spartanburg Medical Center, Spartanburg, South Carolina 29303, United States
Black Hills Obstetrics and Gynecology, Rapid City, South Dakota 57701, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57701, United States
Parkland Memorial Hospital, Dallas, Texas 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas 75390, United States
M D Anderson Cancer Center, Houston, Texas 77030, United States
Aurora Cancer Care-Burlington, Burlington, Wisconsin 53105, United States
Aurora Cancer Care-Southern Lakes, Elkhorn, Wisconsin 53121, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin 53024, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin 54311-6519, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin 53142, United States
Vince Lombardi Cancer Clinic-Marinette, Marinette, Wisconsin 54143, United States
Aurora Advanced Healthcare Inc-Menomonee Falls, Menomonee Falls, Wisconsin 53051, United States
Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin 53209, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin 53215, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin 53233, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin 54017, United States
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin 54904, United States
Aurora Cancer Care-Racine, Racine, Wisconsin 53406-5661, United States
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin 53081, United States
Aurora Medical Center in Summit, Summit, Wisconsin 53066, United States
Vince Lombardi Cancer Clinic, Two Rivers, Wisconsin 54241, United States
Aurora Cancer Care-Waukesha, Waukesha, Wisconsin 53188, United States
Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin 53226, United States
Aurora West Allis Medical Center, West Allis, Wisconsin 53227, United States