Bevacizumab/Doxorubicin/Radiation for Sarcoma - Full Text View

Purpose

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
Sarcoma	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:

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Bevacizumab

Genetic and Rare Diseases Information Center resources: Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

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:	June 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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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 ClinicalTrials.gov identifier: NCT01746238

Contacts


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

Locations


United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Barbara Anderson, RN 617-724-4000 banderson@partners.org
Principal Investigator: Edwin Choy, MD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators


Principal Investigator:	Edwin Choy, MD	Massachusetts General Hospital

More Information


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

Keywords provided by Massachusetts General Hospital:


soft tissue high grade

Additional relevant MeSH terms:


Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Bevacizumab Liposomal doxorubicin Doxorubicin Angiogenesis Inhibitors Angiogenesis Modulating Agents	Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016