Bevacizumab/Doxorubicin/Radiation for Sarcoma
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Sarcoma
Age (in years)
18+
Phase
Phase 1
Participants needed
14
Est. Completion Date
Jan 31, 2025
Treatment type
Interventional
Sponsor
Massachusetts General Hospital
ClinicalTrials.gov identifier
NCT01746238
Study number
12-396
Understanding Clinical Trials
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