Bevacizumab/Doxorubicin/Radiation for Sarcoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Massachusetts General Hospital
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital Identifier:
First received: December 5, 2012
Last updated: March 8, 2016
Last verified: March 2016

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.

Condition Intervention Phase
Drug: Bevacizumab
Drug: Doxorubicin
Radiation: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Bevacizumab, Metronomic Doxorubicin and Radiation Therapy for Resectable Soft Tissue Sarcoma

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Determine MTD of bevacizumab+doxorubicin+radiation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To determine the maximum tolerated dose of bevacizumab when administered concurrently with metronomic doxorubicin and radiation therapy for resectable intermediate and high-grade soft tissue sarcomas

Secondary Outcome Measures:
  • Pathologic response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To determine the pathologic response rate for neoadjuvant bevacizumab, metronomic doxorubicin, and radiation therapy (trimodality therapy) for resectable intermediate and high-risk soft tissue sarcoma

  • gene expression signatures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To confirm gene expression signatures as biomarkers for response to trimodality therapy

  • Obtain preliminary data overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To obtain preliminary data regarding overall survival with trimodality therapy

  • Microvessel density [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To confirm microvessel density as biomarkers for response to trimodality therapy

  • Obtain preliminary data regarding local control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To obtain preliminary data regarding local control with trimodality therapy

  • Obtain preliminary data regarding distant control [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To obtain preliminary data regarding distant control with trimodality therapy

  • Obtain preliminary data disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To obtain preliminary data regarding disease-free survival with trimodality therapy

Estimated Enrollment: 18
Study Start Date: March 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Bevacizumab, metronomic doxorubicin and radiation therapy
Drug: Bevacizumab
Intravenous infusion, every 2 weeks, 3 doses total
Other Name: Avastin
Drug: Doxorubicin
Intravenous infusion, bolus infusion followed by 4 day continuous infusion, every week for 5 weeks
Other Name: Adriamycin
Radiation: Radiation Therapy
Daily, Monday-Friday, for 6 weeks
Other Name: XRT

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01746238

Contact: Barbara Anderson, RN 617-643-2427 BANDERSON15@PARTNERS.ORG

United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Barbara Anderson, RN    617-724-4000   
Principal Investigator: Edwin Choy, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Edwin Choy, MD Massachusetts General Hospital
  More Information

Responsible Party: Edwin Choy, MD, Prinicipal Investigator, Massachusetts General Hospital Identifier: NCT01746238     History of Changes
Other Study ID Numbers: 12-396 
Study First Received: December 5, 2012
Last Updated: March 8, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
soft tissue
high grade

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Liposomal doxorubicin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on April 27, 2016