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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00755261 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma Soft Tissue Sarcoma |
Drug: Avastin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Doxorubicin and Avastin® for Patients With Advanced Soft-tissue Sarcomas. |
| Estimated Enrollment: | 68 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Johns Hopkins SKCCC | |
| Baltimore, Maryland, United States, 21231 | |
| Principal Investigator: | Katherine A Thornton, MD | Johns Hopkins SKCCC |
More Information
| Responsible Party: | Christian Meyer, MD, Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00755261 History of Changes |
| Other Study ID Numbers: | J07133, NA_00013238 |
| Study First Received: | September 17, 2008 |
| Last Updated: | January 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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STS |
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Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Bevacizumab Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |