NCT00755261

Phase II Study of Doxorubicin and Avastin® in Sarcoma.

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sarcoma
• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Avastin	Combination of Avastin and doxorubicin. If initial 90 +/- 15 minute infusion of Avastin is tolerated without fever and chills, the 2nd dose may be infused over 60 +/- 10 minutes. If well tolerated, all subsequent infusions may be delivered over 30 +/- 10 minutes.
DRUG	Doxorubicin	The Day 1 6- hour continuous IV infusion must be done through a central venous catheter.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2008-09-18
• Last updated: 2015-05-08
• Results posted: 2015-05-08

Locations

1 site across 1 country: United States