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Sponsored by: |
Sidney Kimmel Comprehensive Cancer Center |
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Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00755261 |
This research is being done to find out if adding a drug called Avastin to an already approved regimen used for soft-tissue sarcoma (Mesna, Doxorubicin and Ifosfamide) 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 Mesna, Doxorubicin and Ifosfamide.
Condition | Intervention | Phase |
---|---|---|
Sarcoma Soft Tissue Sarcoma |
Drug: Avastin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Doxorubicin, Ifosfamide, and Bevacizumab 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 MAI 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 MAI for the treatment of advanced soft-tissue sarcomas.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
Johns Hopkins SKCCC | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Margaret Fogle, RN 410-955-7349 mfogle1@jhmi.edu |
Principal Investigator: | Katherine A Thornton, MD | Johns Hopkins SKCCC |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center ( Katherine Thornton, MD ) |
Study ID Numbers: | NA_00013238 |
Study First Received: | September 17, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00755261 |
Health Authority: | United States: Food and Drug Administration |
STS |
Neoplasms, Connective and Soft Tissue Ifosfamide Mechlorethamine Malignant mesenchymal tumor Sarcoma |
Bevacizumab Mesna Doxorubicin Soft tissue sarcomas Isophosphamide mustard |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Antibiotics, Antineoplastic Angiogenesis Inhibitors |
Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Antineoplastic Agents, Alkylating Angiogenesis Modulating Agents Alkylating Agents |