CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
sargramostim +3 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/NCT00466960
NCT00466960Phase 2Completed

A Phase II Trial of Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) With Weekly Protein Bound Paclitaxel (Abraxane™) as Chemoimmunotherapy for Platinum-Refractory/Resistant Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancer

University of Washington·interventional·Posted Apr 27, 2007·Updated Aug 28, 2017

In Brief

A Phase 2 clinical trial evaluating sargramostim, paclitaxel albumin-stabilized nanoparticle formulation, and 2 other interventions for Brenner Tumor and 11 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed Summary

RATIONALE: Colony stimulating factors, such as sargramostim (GM-CSF), may stimulate the immune system in different ways and stop tumor cells from growing and may also increase the number of immune cells found in bone marrow or peripheral blood and help the immune system recover from the side effects of chemotherapy. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation may be an effective treatment for ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. PURPOSE: This phase II trial is studying how well giving GM-CSF together with paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that did not respond to previous chemotherapy

Study Details

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 27, 2007
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 19.2 years ago

Interventions

sargramostimbiological

Given SC

paclitaxel albumin-stabilized nanoparticle formulationdrug

Given IV

laboratory biomarker analysisother

Correlative studies

immunologic techniqueother

Correlative studies