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Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Endometrial Clear Cell Adenocarcinoma; Estrogen Receptor Negative; Ovarian Clear Cell Cystadenocarcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Uterine Corpus Carcinoma

Intervention: Dasatinib (Drug); Laboratory Biomarker Analysis (Other)

Phase: Phase 2

Status: Suspended

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
David Hyman, Principal Investigator, Affiliation: NRG Oncology

Summary

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.

Clinical Details

Official title: A Phase II Trial of DCTD-Sponsored Dasatinib (NSC #732517) in Recurrent/Persistent Ovary, Fallopian Tube, Primary Peritoneal, and Endometrial Clear Cell Carcinoma Characterized for the Retention or Loss of BAF250a Expression

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of patients with objective tumor response rate (complete response [CR] or partial response [PR]) using RECIST version 1.1

Secondary outcome:

Duration of overall survival (OS)

Duration of progression-free survival (PFS)

Incidence of adverse effects as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Detailed 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 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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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 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

Locations and Contacts

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

Additional Information

Starting date: February 2014
Last updated: August 18, 2015

Page last updated: August 23, 2015

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