Bevacizumab and Radiation Therapy for Sarcomas

Soft Tissue Sarcoma Clinical Trial

Official title:

A Phase II Study of Neoadjuvant Bevacizumab and Radiation Therapy for Resectable Soft Tissue Sarcomas

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00356031
• Other study ID #: 05-090
• Secondary ID: 1R21CA117128-01A
• Status: Recruiting
• Phase: Phase 2
• First received: July 21, 2006
• Last updated: April 27, 2010
• Start date: July 2006
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Massachusetts General Hospital
• Contact: Yen-Lin Chen, MD
• Phone: 617-726-6876
• Email: ychen9[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosarcoma
• Fibrous Histiocytoma
• Histiocytoma
• Leiomyosarcoma
• Liposarcoma
• Sarcoma
• Sarcoma, Synovial
• Soft Tissue Sarcoma
• Synovial Sarcoma

Intervention

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/

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the objective response rate for neoadjuvant bevacizumab combined with radiation therapy for intermediate and high-risk soft tissue sarcomas.		3 years	No
Secondary	To analyze the biologic effects of this regimen on tumor vasculature, blood flow, and oxygenation		3 years	No
Secondary	to obtain preliminary data regarding local control, distant control, disease-free survival, and overall survival with this regimen.		TBD	No