Clinical trial · Interventional
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
NCT00006227CI-TRIAL-00043822completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Type Ovarian Granulosa Cell Tumor | Adult Ovarian Granulosa Cell Tumor | ALIAS | 0.90 |
| Ovarian Gynandroblastoma | Ovarian Gynandroblastoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Sertoli-Leydig Cell Tumor | Ovarian Sertoli-Leydig Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Ovarian Sex Cord Tumor With Annular Tubules | Ovarian Sex Cord Tumor with Annular Tubules | ONTOLOGY_EXACT | 0.98 |
| Ovarian Steroid Cell Tumor | Ovarian Steroid Cell Tumor | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (paclitaxel)
- description
- Patients receive paclitaxel IV over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Probability of Complete Clinical Response
- timeFrame
- Up to 5 years
- description
- The probability of complete clinical response (i.e. proportion of participants) (assessed using GOG RECIST criteria) of paclitaxel as second line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma
Secondary outcomes (2)
- measure
- Progression-free Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.