Bevacizumab and Radiation Therapy for Sarcomas

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00356031
First received: July 21, 2006
Last updated: April 27, 2010
Last verified: April 2010

July 21, 2006
April 27, 2010
July 2006
March 2010   (final data collection date for primary outcome measure)
To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas.
Complete list of historical versions of study NCT00356031 on ClinicalTrials.gov Archive Site
  • To analyze the biologic effects of this regimen on tumor vasculature, blood flow, and oxygenation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • to obtain preliminary data regarding local control, distant control, disease-free survival, and overall survival with this regimen. [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • To analyze the biologic effects of this regimen on tumor vasculature, blood flow, and oxygenation
  • to obtain preliminary data regarding local control, distant control, disease-free survival, and overall survival with this regimen.
Not Provided
Not Provided
 
Bevacizumab and Radiation Therapy for Sarcomas
A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

The main purpose of this study is to test the effectiveness of bevacizumab in combination with radiation therapy to see what effects (good or bad) they have on patients with soft tissue sarcoma. Bevacizumab is an antibody designed specifically to slow or stop the growth of cancerous tumors by decreasing the blood supply to the tumor. Bevacizumab is approved by the FDA in combination with intravenous 5-fluorouracil-based chemotherapy as a treatment for patients with cancer of the colon or rectum that has spread. However, the use of bevacizumab in combination with radiation for sarcomas is still under investigation.

  • The dose of bevacizumab and radiation therapy will be the same for all participants throughout the study.
  • Bevacizumab will be given as an intravenous infusion every 2 weeks for a total of 4 doses.
  • Radiation therapy will begin 2 weeks after the first bevacizumab infusion and will be delivered 5 days per week over a period of 6 weeks. This is done as an outpatient procedure. Each 2 week period will be considered a separate treatment cycle. Participants will be treated with radiation therapy for a maximum of 3 cycles (6 weeks).
  • A surgeon will evaluate the participants tumor by radiologic studies before study treatment to determine if surgical removal is possible. After the completion of study treatment, a surgeon will repeat the evaluation of the tumor. Surgery will performed 6-7 weeks after the completion of radiation therapy.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Soft Tissue Sarcoma
  • Fibrous Histiocytoma
  • Liposarcoma
  • Leiomyosarcoma
  • Fibrosarcoma
  • Synovial Sarcoma
  • Drug: Bevacizumab
    Given intravenously every 2 weeks for a total of 2 doses
  • Procedure: Radiation Therapy
    Given two weeks after the first bevacizumab infusion and delivered 5 days a week over 6 weeks/
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary soft tissue sarcoma (STS) or an isolated local recurrence of STS. Open incisional biopsy or core biopsies should be performed within 8 weeks prior to registration
  • Tumor grade of intermediate or high grade
  • Tumor must be located on the upper extremity, the lower extremity, trunk, retroperitoneum, or pelvis
  • Primary tumors must be > 5.0cm in maximal diameter and local recurrence can be any size
  • 18 years of age or older
  • Zubrod performance status of 0-2
  • Adequate organ and marrow function

Exclusion Criteria:

  • Metastatic disease
  • Pregnant or lactating women
  • HIV positive patients
  • Prior treatment with radiation, chemotherapy or biotherapy for this tumor
  • History or evidence of CNS disease
  • Serious, non-healing wound, ulcer, or bone fracture
  • Clinically significant cardiovascular disease, NYHA Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or Grade II or greater peripheral vascular disease within 1 year
  • History of stroke within the past 6 months
  • Major surgical procedure or significant traumatic injury within 28 days
  • Current or recent (within 10 days) use of full-dose oral or parenteral anticoagulants or thrombolytic agents.
  • Presence of bleeding diathesis or coagulopathy
  • Proteinuria at baseline or clinically significant impairment of renal function
  • History of abdominal fistula, gastrointestinal perforation, or inta-abdominal abscess within the past 6 months
  • Documented history of uncontrolled seizures
  • Grade 2 or greater sensory neuropathy based upon the NCI CTCAE, version 3.0
  • Known history of deep vein thrombosis or pulmonary embolus
  • Known hypercoagulable disorder
  • History of hepatic cirrhosis or current hepatic dysfunction
Both
18 Years and older
No
Contact: Yen-Lin Chen, MD 617-726-6876 ychen9@partners.org
United States
 
NCT00356031
05-090, 1 R21 CA117128-01A1
Yes
Yen-Lin Chen, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Yen-Lin Chen, MD Massachusetts General Hospital
Massachusetts General Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP