CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
cisplatin +12 moredrug
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/NCT00742924
NCT00742924Phase 1Completed
CompareCT.gov

Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma

Children's Oncology Group·interventional·Posted Aug 28, 2008·Updated Jul 4, 2014

In Brief

A Phase 1 clinical trial evaluating cisplatin, dexrazoxane hydrochloride, and 11 other interventions for Sarcoma. Completed, enrolled 24 participants across 88 sites in 4 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid when given together with combination chemotherapy in treating patients with newly diagnosed metastatic osteosarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoma
CountriesAustralia, Canada, Puerto Rico, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 17.8 years ago

Interventions

cisplatindrug

Given IV

dexrazoxane hydrochloridedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

etoposidedrug

Given IV

ifosfamidedrug

Given IV

leucovorin calciumdrug

Given IV or orally

methotrexatedrug

Given IV

zoledronic aciddrug

Given IV

adjuvant therapyprocedure

neoadjuvant therapyprocedure

therapeutic conventional surgeryprocedure

Surgery of the primary tumor is scheduled for 12 weeks after the commencement of chemotherapy.

filgrastimbiological

Given SC

Mesnadrug

Given IV