Bevacizumab/Doxorubicin/Radiation for Sarcoma

Status: Recruiting
Phase: Phase 1
Diagnosis: Sarcoma
NCT ID: NCT01746238 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-396

 

The main purpose of this study is to test the safety, tolerability, maximum tolerated dose, and effectiveness of bevacizumab in combination with chemotherapy and radiation therapy. Because bevacizumab is not considered standard therapy for sarcomas, it can only be given to subjects with sarcoma who are enrolled in this research study and may only be administered under the direction of doctors who are investigators in this research study. This study is being done because sarcomas can recur after surgical resection (surgery for removal of the tumor), radiation therapy and chemotherapy. This recurrence can occur in the same location as the original tumor or in distant sites such as the lung. Thus better treatments are needed. This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, combination of drugs, or combination of drugs with radiation. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the combination of drugs and radiation is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved bevacizumab with doxorubicin and radiation for your type of cancer.

 

Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Edwin Choy, MD, Massachusetts General Hospital

Site-responsible Investigators:

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Primary soft tissue sarcoma or isolated local recurrent sarcoma without prior radiation - Histologically intermediate- or high-grade soft tissue sarcoma - Determined by an expert sarcoma surgeon to have resectable disease located on the upper extremity, lower extremity, trunk, retroperitoneum or pelvis - Primary tumor must be at least 5 cm in maximal diameter or an isolated local recurrence of any size Exclusion Criteria: - Metastatic disease - Pregnant or breastfeeding - Immunotherapy, chemotherapy, experimental therapy or radiotherapy within 4 weeks of first day of study drug dosing - Previously received doxorubicin, any other anthracycline chemotherapy or bevacizumab - Major surgery within 4 weeks before first day of study drug dosing - Uncontrolled intercurrent illness - History of myocardial infarction, acute coronary syndromes, coronary angioplasty or coronary artery stenting within previous 6 months - Other medical or psychiatric conditions that may interfere with study participation - Known hypercoagulable disorder - Known history of deep vein thrombosis or pulmonary embolus - Presence of bleeding diathesis or coagulopathy - Current use of therapeutic anticoagulants
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