CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Cyclophosphamide and Sirolimusdrug
Likely dose
Cyclophosphamide and Sirolimus 200 mgfrom 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/NCT00743509
NCT00743509Phase 2Completed
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A Phase II Study of Oral Cyclophosphamide and Sirolimus (OCR) in Advanced Sarcoma

University of Michigan Rogel Cancer Center·interventional·Posted Aug 29, 2008·Updated Sep 28, 2015

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide and Sirolimus for Osteosarcoma. Completed, enrolled 49 participants across 1 site.

Detailed Summary

The purpose of this Phase II study will assess the effectiveness of the combination of oral cyclophosphamide and sirolimus in sarcoma patients with relapsed or widespread disease who cannot be cured by surgery, radiation or conventional chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteosarcoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 29, 2008
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2010
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.8 years ago

Interventions

Cyclophosphamide and Sirolimusdrug

The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle. Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously