Colon Cancer Clinical Trial

Bevacizumab and Radiation Therapy for Sarcomas

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 central nervous system (CNS) disease
Serious, non-healing wound, ulcer, or bone fracture
Clinically significant cardiovascular disease, New York Heart Association (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 is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT00356031

Recruitment Status:

Completed

Sponsor:

Massachusetts General Hospital

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There is 1 Location for this study

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Massachusetts General Hospital
Boston Massachusetts, 02114, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT00356031

Recruitment Status:

Completed

Sponsor:


Massachusetts General Hospital

How clear is this clinincal trial information?

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