Bevacizumab/Doxorubicin/Radiation for Sarcoma

NCT01746238 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 12-396
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma

Keywords

soft tissue; high grade

Outcome Measures

Primary Outcomes (1)

• Determine MTD of bevacizumab+doxorubicin+radiation

  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

  2 years

Secondary Outcomes (7)

• Pathologic response rate

  2 years

• gene expression signatures

  2 years

• Obtain preliminary data overall survival

  2 years

• Microvessel density

  2 years

• Obtain preliminary data regarding local control

  2 years

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Bevacizumab, metronomic doxorubicin and radiation therapy

Drug: Bevacizumab; Drug: Doxorubicin; Radiation: Radiation Therapy

Interventions

Bevacizumab DRUG

Intravenous infusion, every 2 weeks, 3 doses total

Also known as: Avastin

Treatment Arm

Doxorubicin DRUG

Intravenous infusion, bolus infusion followed by 4 day continuous infusion, every week for 5 weeks

Also known as: Adriamycin

Treatment Arm

Radiation Therapy RADIATION

Daily, Monday-Friday, for 6 weeks

Also known as: XRT

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Bevacizumab; Doxorubicin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Therapeutics

Study Officials

• Edwin Choy, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 5, 2012
• First Posted: December 10, 2012
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)