CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
filgrastim +6 morebiological
Likely dose
Gemcitabine followed by docetaxel (sequential regimen; specific doses not stated in trial record)AI-extracted
Key inclusion· 9
  • Histologically confirmed recurrent high-grade Ewing's sarcoma with progressive disease after standard therapy
  • Histologically confirmed high-grade osteosarcoma (closed to accrual as of 12/21/06) with progressive disease after standard therapy
  • Histologically confirmed unresectable or locally recurrent chondrosarcoma unable to be completely resected
  • At least 1 unidimensionally measurable lesion by medical imaging techniques
Key exclusion· 8
  • More than 2 additional salvage regimens for Ewing's sarcoma or osteosarcoma
  • Prior gemcitabine therapy
  • Prior taxane therapy
  • Prior allogeneic transplantation

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

Search/NCT00073983
NCT00073983Phase 2Completed

Phase II Study Of Sequential Gemcitabine Followed By Docetaxel For Recurrent Ewing's Sarcoma, Osteosarcoma, Or Unresectable Or Locally Recurrent Chondrosarcoma [SARC Study]

Sarcoma Alliance for Research through Collaboration·interventional·Posted Dec 11, 2003·Updated Mar 12, 2012

In Brief

A Phase 2 clinical trial evaluating filgrastim, pegfilgrastim, and 5 other interventions for Sarcoma. Completed, enrolled 54 participants.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in treating patients who have recurrent osteosarcoma, recurrent Ewing's sarcoma, or unresectable or locally recurrent chondrosarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2003
Enrollment StartOct 1, 2006
Primary CompletionJan 1, 2010
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 22.6 years ago

Interventions

filgrastimbiological

filgrastim

pegfilgrastimbiological

pegfilgrastim

docetaxeldrug

docetaxel

gemcitabine hydrochloridedrug

gemcitabine hydrochloride

microarray analysisgenetic

microarray analysis

laboratory biomarker analysisother

laboratory biomarker analysis

pharmacokinetic studyother

pharmacokinetic study