Proton Therapy and Bevacizumab for Primary Liver Tumors

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Brief Title

Proton Therapy and Bevacizumab for Primary Liver Tumors

Official Title

Phase I Study of Proton Radiotherapy and Bevacizumab for Primary Liver Tumors

Brief Summary

      Primary Objectives:

        1. To evaluate the safety of the treatment of patients with technically or medically
           inoperable hepatocellular carcinoma and cholangiocarcinoma with proton therapy and
           concurrent bevacizumab biotherapy.

        2. To identify the maximum tolerated dose (MTD) using this combination.

      Secondary Objectives:

        1. To evaluate local control rate within the radiation field, hepatic control rate outside
           the treatment field, time to radiographic progression and 2 year survival rate.

        2. To analyze dose-volume characteristics that influence the development of radiation
           induced liver disease (RILD) and GI bleeds that may occur.

        3. To assess quality of life during and after chemoradiation therapy.
    

Detailed Description

      Proton beams are designed to deliver a high dose of radiation to the abnormal tissues while
      sparing surrounding normal tissues. Bevacizumab is a biotherapy that is designed to prevent
      or slow down the growth of cancer cells by blocking the growth of blood vessels.

      Before you can start treatment on this study, you will have "screening tests." These tests
      will help the doctor decide if you are eligible to take part in this study. You will have a
      complete physical exam. Blood (about 2 tablespoons) and urine will be collected for routine
      tests. You will have chest x-rays and a computed tomography (CT) scan of your abdomen
      (stomach area) and pelvis. Women who are able to have a children must have a negative urine
      pregnancy test.

      You will then have a radiation treatment planning session called a simulation. You will get a
      CT scan of your abdomen, and marks will be placed on your skin to help guide the radiation
      treatments when you return for the actual treatments. At around the same time, you will
      receive your first dose of bevacizumab through a needle in your vein. The infusion will at
      first last 90 minutes. If there are no allergic reactions, fevers, or chills, the infusion
      will be shortened to 60 minutes and then 30 minutes for later infusions. Your second dose of
      bevacizumab will be given with the start of radiation therapy treatments. Your final dose of
      bevacizumab will be given 2 weeks later. You will receive radiation therapy once a day, for 5
      days in a row (Monday-Friday) for 4 weeks (total of 20 treatments).

      During this study, you will have physical exams weekly during treatment, 1 month after the
      last proton beam therapy visit and then every 3 months thereafter. Every week, while
      receiving proton beam therapy, blood (about 2 teaspoons) will be drawn to check for any side
      effects. You will be asked about any side effects you may be experiencing.

      You may remain on study for as long as you are benefitting. You will be taken off study if
      the disease gets worse or intolerable side effects occur.

      After participation in this study is over, you will have follow-up evaluation every 3 months
      for 2 years. During these visits, you will have a physical exam. You will have CT scans.
      Blood (about 2 teaspoons) will be drawn for routine tests.

      This is an investigational study. Bevacizumab is FDA approved and commercially available for
      the treatment of metastatic colon cancer. The use of bevacizumab with proton beam therapy is
      investigational. Up to 30 patients will take part in this study. All will be enrolled at M.
      D. Anderson.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Toxicity (during and within 1 month after completion of radiotherapy)


Condition

Liver Cancer

Intervention

Bevacizumab

Study Arms / Comparison Groups

 Proton Therapy + Bevacizumab
Description:  Proton Therapy + Bevacizumab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

3

Start Date

May 2007

Completion Date

November 2009

Primary Completion Date

November 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Cytologic or histologic proof of primary liver cancer (hepatocellular carcinoma or
             cholangiocarcinoma). Patients with non-metastatic, unresectable disease are eligible.
             Patients with positive margins after surgical resection are eligible. Metastasis is
             defined as unequivocal evidence of extrahepatic disease based on CT imaging, excluding
             nodal disease.

          -  Tumors must not be greater than 10cm (small satellite lesions around a larger lesion
             are allowed), all of which can be encompassed in a radiation treatment field (as
             assessed by the radiation oncologist).

          -  Prior chemotherapy, transarterial chemoembolization and radiofrequency ablation are
             permitted. A minimum of four weeks must have elapsed between prior treatment and
             planned protocol therapy.

          -  Prior liver resection is permitted as long as the interval between surgery and
             enrollment is at least 4 weeks.

          -  Karnofsky performance status >/= 70 are eligible.

          -  There is no age restriction.

          -  Absolute granulocyte count >/= 1,500 cells/mm3, hemoglobin >/= 8 gm/dL and platelet
             count >/= 80,000 cells/mm3.

          -  Serum creatinine  1.0 at screening OR Urine dipstick for proteinuria > 2+ (patients discovered
             to have > 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour
             urine collection and must demonstrate < 1g of protein in 24 hours to be eligible).

          -  Patients currently receiving anticoagulation treatment with coumadin, low molecular
             weight heparin or IV heparin. Evidence of bleeding diathesis or coagulopathy.
             Anticoagulation for line maintenance is permitted.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study; fine needle aspirations or core biopsies within 7 days prior to Day 0.

          -  Serious, nonhealing wound, ulcer, or bone fracture.

          -  Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood
             pressure of >150/100 mmHg on medication], history of myocardial infarction within 6
             months, unstable angina), New York Heart Association (NYHA) Class II or greater
             congestive heart failure, unstable symptomatic arrhythmia requiring medication
             (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal
             supraventricular tachycardia are eligible), or Class II or greater peripheral vascular
             disease.

          -  History of aneurysms, strokes, transient ischemic attacks, and arteriovenous
             malformations within 6 months.

          -  Prior unanticipated severe reaction to bevacizumab.

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to Day 0

          -  Patients who have had an organ allograft.

          -  Pregnant women are excluded from this study; women of childbearing potential must
             agree to practice adequate contraception (oral, injectable, or implantable hormonal
             contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with
             spermicide; or vasectomized partner) and to refrain from breast feeding, as specified
             in the informed consent. Women of child-bearing potential are defined as those women
             who have not had surgical sterilization or been menopausal for 12 consecutive months.

          -  Male patients must agree not to father a child and must agree to use a condom.

          -  Prior radiation therapy to an upper abdominal or lower thoracic field that could
             overlap with the proposed treatment field.

          -  Serious concomitant medical or psychiatric disorders that place the patient at high
             risk for non-compliance with or morbidity due to protocol therapy.

          -  Patients with a history of hypertension must be well-controlled (					

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Sunil Krishnan, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00426829

Organization ID

2005-0881


Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 Genentech, Inc.

Study Sponsor

Sunil Krishnan, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2012