A Phase II Evaluation of Dasatinib (Sprycel®, NSC #732517) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
4 other identifiers
interventional
35
1 country
20
Brief Summary
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedResults Posted
Study results publicly available
July 18, 2014
CompletedApril 15, 2016
March 1, 2016
2.5 years
May 2, 2008
January 31, 2014
March 17, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Progression-free Survival at 6 Months
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Scans to assess progression were done every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Tumor Response
Complete and Partial Tumor Response by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Per RECIST v1.0 for target lesions and assessed by MRIor CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. CT scan or MRI is used to follow lesion for measurable disease every other cycle for the first 6 months; every three months thereafter; and at any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease or rising serum tumor marker levels. Responses must be confirmed by repeat imaging 4 weeks following documentation of response.
Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Secondary Outcomes (3)
Frequency and Severity of Adverse Events as Assessed by CTCAE v3.0
Every cycle during treatment
Progression-free Survival
Every other cycle for the first 6 months; every three months thereafter; and any time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.
Overall Survival
Every other cycle up to 5 years
Study Arms (1)
Treatment (dasatinib)
EXPERIMENTALPatients receive oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
- All patients must have measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded); each lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT
- Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; 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
- Patients must not be eligible for a higher priority GOG protocol, if one exists; in general, this would refer to any active GOG Phase III protocol for the same patient population
- 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 a GOG Performance Status of 0 or 1
- Recovery from effects of recent surgery, radiotherapy, or chemotherapy
- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated UTI).
- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
- Any other prior therapy directed at the malignant tumor, including immunologic agents, must be discontinued at least three weeks prior to registration; six weeks for patient previously treated with monoclonal antibodies
- Prior therapy
- 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, high-dose therapy, consolidation, non-cytotoxic agents 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
- Note: patients on this non-cytotoxic study are allowed to receive additional cytotoxic chemotherapy for management of recurrent or persistent disease, as defined above
- Patients must have NOT received any non-cytotoxic therapy for management of recurrent or persistent disease; patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen
- +16 more criteria
You may not qualify if:
- Patients who have had previous treatment with dasatinib
- Patients who have received radiation to more than 25% of marrow-bearing areas
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
- Patients cannot take St. John's Wort or drink grapefruit juice while on study treatment (discontinue St. John's Wort at least five days before starting dasatinib)
- Patients receiving IV bisphosphonates agree that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia, and may be restarted only if any hypocalcemia has been corrected
- Patients who have a history of cardiac disease:
- Uncontrolled angina, congestive heart failure (CHF) or myocardial infarction (MI) within six months prior to study entry;
- Diagnosed congenital long QT syndrome;
- Clinically significant ventricular arrhythmias (such as ventricular tachycardia \[VT\], ventricular fibrillation \[VF\], or Torsades de pointes)
- Patients with hypokalemia or hypomagnesemia if it cannot be corrected to within normal limits prior to dasatinib treatment
- Patients who have a history of significant bleeding disorder unrelated to cancer including:
- Bleeding diathesis, congenital or acquired within one year prior to initiating protocol therapy (e.g., von Willebrand's disease, acquired anti-factor VIII antibodies);
- Significant GI bleeding within three months prior to initiating protocol therapy
- Dasatinib is metabolized primarily by the CYP3A4 liver enzyme; consideration should be given to using alternative medications not impacting CYP3A4 while on dasatinib therapy
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (20)
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, 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
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Women and Infants Hospital
Providence, Rhode Island, 02905, United States
AnMed Health Cancer Center
Anderson, South Carolina, 29621, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, 29303, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jessalyn Reboy
- Organization
- Gynecologic Oncology Group Statistical and Data Center
Study Officials
- PRINCIPAL INVESTIGATOR
Russell Schilder
Gynecologic Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 5, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2010
Last Updated
April 15, 2016
Results First Posted
July 18, 2014
Record last verified: 2016-03