Trials / Completed
CompletedNCT00006227
Paclitaxel in Treating Patients With Ovarian Stromal Cancer
Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the probability of clinical response and toxicity of paclitaxel as second-line chemotherapy in measurable disease patients with malignant tumors of the ovarian stroma. II. To evaluate the value of inhibin for predicting response. OUTLINE: Patients receive paclitaxel intravenously (IV) over 3 hours on day 1. Treatment continues every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, then every 6 months for three years, and then annually thereafter.
Conditions
- Adult Type Ovarian Granulosa Cell Tumor
- Ovarian Gynandroblastoma
- Ovarian Sertoli-Leydig Cell Tumor
- Ovarian Sex Cord Tumor With Annular Tubules
- Ovarian Steroid Cell Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paclitaxel | Given IV |
Timeline
- Start date
- 2000-11-20
- Primary completion
- 2016-07-16
- Completion
- 2016-07-16
- First posted
- 2003-01-27
- Last updated
- 2020-03-05
- Results posted
- 2020-03-05
Locations
98 sites across 2 countries: United States, Japan
Source: ClinicalTrials.gov record NCT00006227. Inclusion in this directory is not an endorsement.