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Bevacizumab/Doxorubicin/Radiation for Sarcoma

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ClinicalTrials.gov Identifier: NCT01746238
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Edwin Choy, MD, Massachusetts General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Sarcoma Drug: Bevacizumab Drug: Doxorubicin Radiation: Radiation Therapy Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Bevacizumab, Metronomic Doxorubicin and Radiation Therapy for Resectable Soft Tissue Sarcoma
Actual Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Determine MTD of bevacizumab+doxorubicin+radiation [ Time Frame: 2 years ]
    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 :
  1. Pathologic response rate [ Time Frame: 2 years ]
    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

  2. gene expression signatures [ Time Frame: 2 years ]
    To confirm gene expression signatures as biomarkers for response to trimodality therapy

  3. Obtain preliminary data overall survival [ Time Frame: 2 years ]
    To obtain preliminary data regarding overall survival with trimodality therapy

  4. Microvessel density [ Time Frame: 2 years ]
    To confirm microvessel density as biomarkers for response to trimodality therapy

  5. Obtain preliminary data regarding local control [ Time Frame: 2 years ]
    To obtain preliminary data regarding local control with trimodality therapy

  6. Obtain preliminary data regarding distant control [ Time Frame: 2 years ]
    To obtain preliminary data regarding distant control with trimodality therapy

  7. Obtain preliminary data disease-free survival [ Time Frame: 2 years ]
    To obtain preliminary data regarding disease-free survival with trimodality therapy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746238


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Edwin Choy, MD Massachusetts General Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edwin Choy, MD, 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