Spots Global Cancer Trial Database for Phase II Study of Doxorubicin and Avastin® in Sarcoma.

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Trial Identification

Brief Title: Phase II Study of Doxorubicin and Avastin® in Sarcoma.

Official Title: Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas.

Study ID: NCT00755261

Conditions

Sarcoma

Soft Tissue Sarcoma

Interventions

Avastin

Doxorubicin

Study Description

Brief Summary: This research is being done to find out if adding a drug called Avastin to an already approved regimen used for soft-tissue sarcoma, Doxorubicin, will improve overall survival, and slow disease progression. The study will also evaluate the overall safety of combining these drugs. It is not known if combining these drugs will improve outcome. Avastin has been approved for the treatment of metastatic carcinoma of the colon or rectum. It is not approved for the treatment of soft-tissue sarcoma when added to Doxorubicin.

Detailed Description: The rationale for this trial is to improve the efficacy of prototypical anti-sarcoma chemotherapeutic regimen Doxorubicin when combined with Avastin®. Soft tissue sarcomas are highly vascular tumors and are therefore ideally suited to trials combining angiogenic inhibitors with chemotherapy. Several studies have revealed correlations between prognosis and surrogates for angiogenesis, including microvessel density, and circulating VEGF and basic fibroblast growth factor (bFGF). The aim of this study is to evaluate the safety and efficacy of Avastin® in combination with Doxorubicin for the treatment of advanced soft-tissue sarcomas.