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Spots Global Cancer Trial Database for Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma

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Trial Identification

Brief Title: Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma

Official Title: A Multi-Institutional, Open-Label, Phase II Study Of Doxorubicin And Bevacizumab (Anti-VEFG Monoclonal Antibody, NSC 704865) For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma

Study ID: NCT00052390

Conditions

Sarcoma

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma.

Detailed Description: OBJECTIVES: * Determine the response rate (partial and complete) in patients with locally recurrent or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab. * Determine the tolerability of this regimen in these patients. * Determine the toxicity profile of this regimen in these patients. * Determine whether pre-treatment plasma vascular endothelial growth factor level or microvessel density of tumor samples from these patients predicts response to this regimen. OUTLINE: This is a multicenter study. Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease after reaching the maximum dose of doxorubicin may continue bevacizumab alone. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 13.3 months.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Huntsman Cancer Institute, Salt Lake City, Utah, United States

Contact Details

Name: Robert Maki, MD, PhD

Affiliation: Memorial Sloan Kettering Cancer Center

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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