Gemcitabine and Docetaxel in Treating Patients With Recurrent Osteosarcoma (Closed to Accrual as of 12/21/06) or Ewing’s Sarcoma or Unresectable or Locally Recurrent Chondrosarcoma

TYPE OF SARCOMA: Recurrent Ewing’s Sarcoma, Osteosarcoma, or Unresectable or Locally Recurrent Chondrosarcoma
DRUG: Gemcitabine and Docetaxel
ACCRUAL STATUS: Completed

OVERALL STUDY PRINCIPAL INVESTIGATORS:
Shreyas Patel, MD
MD Anderson Cancer Center

Elizabeth Fox, MD
St. Jude Children’s Research Hospital

CLINICALTRIALS.GOV IDENTIFIER: NCT00073983

FOR STUDY DETAILS AND ELIGIBILITY CRITERIA: CLINICALTRIALS.GOV

IMPACT STATEMENT:
Based on strong preclinical data indicating that  gemcitabine and docetaxel were synergistic, SARC embarked on this Bayesian design phase 2 trial of the combination of gemcitabine and docetaxel  in separate cohorts of patients with relapsed or refractory OS, EWS or CS. Proof of principle activity was documented in each cohort but did not meet the ambitious pre-specified targets. The trial was terminated early due to slow accrual. This regimen continues to be used as a standard of care option in the absence of better alternative options.

PUBLICATION:
Fox E, Patel S, Wathen JK, Schuetze S, Chawla S, Harmon D, Reinke D, Chugh R, Benjamin RS, Helman LJ. Phase II study of sequential gemcitabine followed by docetaxel for recurrent Ewing sarcoma, osteosarcoma, or unresectable or locally recurrent chondrosarcoma: results of Sarcoma Alliance for Research Through Collaboration Study 003. Oncologist. 2012;17(3):321. doi: 10.1634/theoncologist.2010-0265. Epub 2012 Feb 23. PMID: 22363068; PMCID: PMC3316916.

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