Comparison of Gemcitabine v. Gemcitabine Plus Docetaxel in Unresectable Soft Tissue Sarcoma

TYPE OF SARCOMA: Unresectable soft tissue sarcoma
DRUG: Gemcitabine and Docetaxel
ACCRUAL STATUS: Completed

OVERALL STUDY PRINCIPAL INVESTIGATOR:
Robert Maki, MD, PhD
Memorial Sloan Kettering Cancer Center

CLINICALTRIALS.GOV IDENTIFIER: NCT00142571

FOR STUDY DETAILS AND ELIGIBILITY CRITERIA: CLINICALTRIALS.GOV

IMPACT STATEMENT:
This was the first randomized study of systemic therapy in metastatic soft tissue sarcomas to show a statistically significant survival advantage of one treatment over another. Usefulness of gemcitabine and docetaxel was seen to be greater in undifferentiated pleomorphic sarcoma and pleomorphic liposarcoma than previously appreciated.

PUBLICATION:
Maki RG, Wathen JK, Patel SR, Priebat DA, Okuno SH, Samuels B, Fanucchi M, Harmon DC, Schuetze SM, Reinke D, Thall PF, Benjamin RS, Baker LH, Hensley ML. Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected]. J Clin Oncol. 2007 Jul 1;25(19):2755-63. doi: 10.1200/JCO.2006.10.4117. Erratum in: J Clin Oncol. 2007 Aug 20;25(24):3790. PMID: 17602081.

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