Paclitaxel in Treating Patients With Ovarian Stromal Cancer (NCT00006227) | Clinical Trial Compass
CompletedPhase 2
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
United States31 participantsStarted 2000-11-20
Plain-language summary
This phase II trial studies the effectiveness of paclitaxel in treating patients who have ovarian stromal cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Who can participate
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with histologically confirmed ovarian stromal tumor (granulosa cell tumor, granulosa cell-theca cell tumor, Sertoli-Leydig cell tumor \[androblastoma\], steroid \[lipid\] cell tumor, gynandroblastoma, unclassified sex cord stromal tumor, sex cord tumor with annular tubules)
* Patients must have recurrent stromal tumor having received no more than one prior chemotherapy regimen
* Patients must have measurable disease as defined by Gynecological Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* White blood count equal to or greater than 3000/mcl
* Granulocyte count equal to or greater than 1500/mcl
* Platelet count equal to or greater than 100,000/mcl
* Creatinine equal to or less than 2.0 mg%
* Bilirubin less than or equal to 1.5 times normal
* Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 times normal
* Patients with a GOG performance grade of 0, 1 or 2
* Patients of child bearing potential must have a negative pregnancy test and must agree to practice an effective means of birth control
* Patients who have met the pre-entry requirements as specified
* Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Exclusion Criteria:
* Patients with GOG performance grade of 3 or 4
* Patients with a prior invasive malignancy (except non-melanoma skin cancer) who have had any evidence of disease within the…