Radiosensitization of AVASTIN® (Bevacizumab) With Stereotactic Body Radiotherapy for Colorectal Liver Metastasis (SBRT-Avastin)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Sunnybrook Health Sciences Centre.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Dr. Yoo-Joung Ko, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01569984
First received: March 30, 2012
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

This is a single-centre, single-arm open-label proof-of-concept study to analyze the imaging (DCE-CT,CEUS and Quantitative US) effects of neoadjuvant bevacizumab and SBRT on colorectal metastases to the liver. Patients will receive 2 doses of bevacizumab 5mg/kg IV prior to SBRT. The second dose of bevacizumab will be given 2 weeks after the first dose of bevacizumab and within 48 hours of starting the first dose of SBRT. The SBRT prescription dose will be up to 60 Gy in 6 fractions, delivered on alternating weekdays for 2 weeks. Total SBRT dose will be determined by size of target lesion, liver sparing and organs-at-risk dose constraints. DCE-CT, CEUS and Quantitative US will be performed within 7 days prior to the first dose of bevacizumab, after the second dose of bevacizumab and within 7 days of completing SBRT.


Condition Intervention Phase
Colorectal Cancer.
Radiation: Stereotactic body radiotherapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single-Centre, Phase II Study for Radiosensitization of AVASTIN® (Bevacizumab) With Stereotactic Body Radiotherapy (SBRT) for Colorectal Liver Metastasis (SBRT Avastin)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Tumor perfusion [ Time Frame: day 24 ] [ Designated as safety issue: No ]
    Tumor perfusion as measured by DCE-CT


Secondary Outcome Measures:
  • Blood flow [ Time Frame: Day 24 ] [ Designated as safety issue: No ]
    Contrast Enhanced Ultrasound


Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Avastin, SBRT
2 treatments of avastin followed by 6 treatments of SBRT every other day.
Radiation: Stereotactic body radiotherapy
Avastin 7.5 mg/kg IV x 2 doses 14 days apart
Other Name: Bevacizumab

Detailed Description:

This is a single-centre, single-arm open-label proof-of-concept study to analyze the imaging (DCE-CT,CEUS and Quantitative US) effects of neoadjuvant bevacizumab and SBRT on colorectal metastases to the liver. Patients will receive 2 doses of bevacizumab 5mg/kg IV prior to SBRT. The second dose of bevacizumab will be given 2 weeks after the first dose of bevacizumab and within 48 hours of starting the first dose of SBRT. The SBRT prescription dose will be up to 60 Gy in 6 fractions, delivered on alternating weekdays for 2 weeks. Total SBRT dose will be determined by size of target lesion, liver sparing and organs-at-risk dose constraints. DCE-CT, CEUS and Quantitative US will be performed within 7 days prior to the first dose of bevacizumab, after the second dose of bevacizumab and within 7 days of completing SBRT.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological and/or cytological diagnosis of colorectal cancer with liver metastases confirmed on imaging scans
  2. 1-3 liver metastatic lesions confirmed on imaging scans
  3. Maximum size of target metastatic lesion is 6 cm or less
  4. At least 700 cc of liver uninvolved by tumour
  5. Previous liver resection, systemic therapy or local ablation therapy is allowed. Extrahepatic disease is allowed if maximum involved organs (including the liver) is 3 or less (i.e. oligometastases).
  6. Child-Pugh's A liver function
  7. Male or female: Age ≥ 18 years
  8. Life expectancy > 3 months
  9. ECOG PS < 2
  10. Prior bevacizumab is permitted as long as last dose >28 days from registration
  11. Laboratory Requirements - within 7 days prior to registration: Hematology

    • neutrophils ≥ 1.5 x 109/L
    • platelets ≥ 100 x 109/L
    • hemoglobin ≥ 90 g/L Biochemistry
    • bilirubin ≤ 1.5 x upper limit of normal
    • serum creatinine ≤ 1.5 x upper limit of normal
    • AST ≤ 3 x upper limit of normal (≤ 5 x if liver metastases present)
    • ALT ≤ 3 x upper limit of normal (≤ 5 x if liver metastases present)
    • INR ≤ 1.3 Urinalysis
    • Proteinuria ≤ grade 1 (by dipstick)
  12. Patients are willing to provide informed consent.
  13. Patients must be accessible for treatment and follow up. Patients registered on this trial must be treated and followed at the participating centre

Exclusion Criteria:

  1. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to registration (i.e. patients must have recovered to less than or equal to grade 1 from any major surgery), or anticipation of need for major surgical procedure during or within 7 weeks after chemo-radiotherapy.
  2. Known to have clinical or radiological evidence of CNS metastases.
  3. Patients with a past or current history (within last 2 years) of other malignancies, except for the indication under this study and curatively treated basal and squamous skin cancer or in-situ cancer of the cervix. Prior treatment of localized prostate cancer is permitted if treatment was greater than 5 years ago and the patient currently has no biochemical evidence of recurrence.
  4. Active hepatitis (infectious or non-infectious)
  5. Patients with known history or present encephalopathy
  6. Gross clinically detectable ascites
  7. Women of childbearing potential with a positive pregnancy test at baseline or lactating. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non childbearing potential. Females patients must not be pregnant or become pregnant during this study and for 6 months after the last dose of bevacizumab.
  8. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study. Patients of childbearing potential must be willing to use a reliable method of birth control. i.e.:double barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device or tubal ligation during the study.
  9. Prior radiotherapy to the right upper quadrant of the liver
  10. Known hypersensitivity reaction to bevacizumab
  11. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanised antibodies
  12. Uncontrolled hypertension, defined as SBP > 150/100 on more than one occasion that does not respond to therapy with antihypertensive agents or being treated with more than 2 anti-hypertensive medications.
  13. Any other serious intercurrent illness such as cardiovascular disease, HIV or any neurological disease.
  14. Patients taking other approved or investigational drug/anticancer treatment (other than ongoing androgen ablation and oral prednisone which are permitted) during the study period, including chemotherapy, biological response modifiers, immunotherapy, surgery or radiotherapy.
  15. Patients concurrently participating in another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569984

Contacts
Contact: Yoo-Joung Ko, MD 416-480-5847 yoo-joung.ko@sunnybrook.ca
Contact: Hans Chung, MD 416-480-4834 hans.chung@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Yoo-Joung Ko, MD    416-480-5847    yoo-joung.ko@sunnybrook.ca   
Contact: Hans Chung, MD    416-480-4834    hans.chung@sunnybrook.ca   
Sponsors and Collaborators
Dr. Yoo-Joung Ko
Roche Pharma AG
Investigators
Principal Investigator: Yoo-Joung Ko, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Dr. Yoo-Joung Ko, Medical Oncoolgist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01569984     History of Changes
Other Study ID Numbers: OZM-032
Study First Received: March 30, 2012
Last Updated: April 3, 2012
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Colorectal

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014