CI

At a glance

ClinicalIndex Comparison Record
Phase 2Unknown· 63 enrolled
Drug / intervention
Bleomycin Sulfate +5 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT01042522
NCT01042522Phase 2Unknown

A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord-Stromal Tumors of the Ovary

GOG Foundation·interventional·Posted Jan 5, 2010·Updated Jan 25, 2022

In Brief

A Phase 2 clinical trial evaluating Bleomycin Sulfate, Carboplatin, and 4 other interventions for Ovarian Granulosa Cell Tumor and 6 related conditions. Targeting 63 participants across 219 sites.

Detailed Summary

This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

Study Details

Timeline

Phase 2UnknownOverdue
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 5, 2010
Enrollment StartFeb 8, 2010
Primary CompletionJun 12, 2020
Study CompletionNov 2, 2022
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 16.5 years ago

Interventions

Bleomycin Sulfatebiological

Given IV

Carboplatindrug

Given IV

Cisplatindrug

Given IV

Etoposide Phosphatedrug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Paclitaxeldrug

Given IV