Phase 2
N=31
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Adult Type Ovarian Granulosa Cell Tumor · Ovarian Gynandroblastoma · Ovarian Sertoli-Leydig Cell Tumor · Ovarian Sex Cord Tumor With Annular Tubules · Ovarian Steroid Cell Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00006227 ↗Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Mar 2020
Primary outcome: Primary: Probability of Complete Clinical Response — 3.2 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Gynecologic Oncology Group
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability of Complete Clinical Response |
3.2 | — |
| SECONDARY Progression-free Survival |
10.0 | — |
| SECONDARY Overall Survival |
73.6 | — |
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.
Eligibility Criteria
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 last 5 years or whose prior malignancy treatment contraindicates the current protocol therapy
- Patients having received more than one prior chemotherapy regimen
- Patients amenable to cure by surgery
- Patients with prior radiation except for those whose recurrent disease is outside the radiation port
Data sourced from ClinicalTrials.gov (NCT00006227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.