Bevacizumab and Radiation Therapy for Sarcomas

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-03-31

Brief Summary

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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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Detailed Description

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* 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.

Conditions

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Soft Tissue Sarcoma Fibrous Histiocytoma Liposarcoma Leiomyosarcoma Fibrosarcoma Synovial Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bevacizumab, Radiation, and Surgery

Bevacizumab 5mg/kg, external beam radiation therapy (XRT), surgery, Intraoperative radiation therapy (IORT), and postoperative external beam radiation therapy (Post-op XRT)

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses

Radiation Therapy

Intervention Type RADIATION

External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.

Surgery

Intervention Type PROCEDURE

Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.

Interventions

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Bevacizumab

Bevacizumab 5mg/kg given intravenously every 2 weeks for a total of 4 doses

Intervention Type DRUG

Radiation Therapy

External beam radiation given two weeks after the first bevacizumab infusion and delivered 5 days a week at 1.8 Gy per day, over 6 weeks. Total radiation dose is 50.4 Gy. For patients with tumors in the retroperitoneum or pelvis, intraoperative radiation therapy (10-20 Gy) may be given for close or positive margins at the discretion of the radiation oncologist and surgeon. For patients with tumors in the extremity or trunk, post-operative external beam radiation therapy (10-20 Gy) will be given for close or positive margins assuming wound healing is good.

Intervention Type RADIATION

Surgery

Surgical resection is performed 6-7 weeks after completion of neoadjuvant therapy.

Intervention Type PROCEDURE

Other Intervention Names

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Avastin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No