Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial … (NCT02059265) | Clinical Trial Compass
TerminatedPhase 2
Dasatinib in Treating Patients With Recurrent or Persistent Ovarian, Fallopian Tube, Endometrial or Peritoneal Cancer
Stopped: Interim monitoring
United States35 participantsStarted 2014-02-14
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 …
What they're measuring
1
Proportion of Patients With Objective Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) Using RECIST Version 1.1
Timeframe: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months; then every 3 months x 2; then every 6 months thereafter until disease progression for up to 5 years.