CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Paclitaxeldrug
Likely dose
Paclitaxel given IVAI-extracted
Key inclusion· 4
  • ✓Histologically confirmed ovarian stromal tumor (granulosa cell, Sertoli-Leydig, steroid cell, gynandroblastoma, sex cord tumor with annular tubules, or unclassified sex cord stromal tumor)
  • ✓Recurrent disease with no more than one prior chemotherapy regimen
  • ✓Measurable disease by GOG RECIST criteria
  • ✓GOG performance status 0, 1, or 2
Key exclusion· 5
  • ✕More than one prior chemotherapy regimen
  • ✕GOG performance status 3 or 4
  • ✕Prior invasive malignancy within 5 years (except non-melanoma skin cancer)
  • ✕Disease amenable to cure by surgery

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00006227
NCT00006227Phase 2Completed
CompareCT.gov

Phase II Study of Paclitaxel for Ovarian Stromal Tumors as Second-Line Therapy

Gynecologic Oncology Group·interventional·Posted Jan 27, 2003·Updated Mar 5, 2020

In Brief

A Phase 2 clinical trial evaluating Paclitaxel for Adult Type Ovarian Granulosa Cell Tumor and 4 related conditions. Completed, enrolled 31 participants across 98 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Type Ovarian Granulosa Cell Tumor, Ovarian Gynandroblastoma, Ovarian Sertoli-Leydig Cell Tumor, Ovarian Sex Cord Tumor With Annular Tubules, Ovarian Steroid Cell Tumor
CountriesJapan, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 20, 2000
Primary CompletionJul 16, 2016
TodayJul 2, 2026
Enrollment to primary: 15.7 yearsPosted 23.4 years ago

Interventions

Paclitaxeldrug

Given IV