Molecular imaging with radiolabeled bevacizumab in metastatic colon carcinoma. A feasibility study in patients who do show response on bevacizumab therapy

Completed

Conditions: colon cancer
10017990

Registration Number: NL-OMON30912

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

1. Metastatic colon cancer.
2. Decrease in CEA levels [-25%] after the 1st or 2nd cycle of first line chemotherapy, including bevacizumab, or decrease in size of measurable valuable lesion.
3. At least 18 years of age.
4. A life expectancy of at least 3 months.
5. Adequate hematologic, hepatic, and renal function.
6. Signed written informed consent.
7. Able to comply with the protocol.

Exclusion Criteria

1. Prior chemotherapy or biological therapy for metastatic disease.
2. Radiotherapy within 14 days before the start of the study of the involved area.
3. Major surgery within 28 days before the initiation of the study.
4. Clinically significant cardiovascular disease.
5. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause.
6. CNS metastases (CT-scan not mandatory).
7. Treatment with any investigational drug within 30 days before the start of the study.
8. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety assessments will consist of evaluating labatory parameters and adverse<br /><br>events according to NCI CTCAE 3.0.<br /><br>The following variables will be analyzed to assess the effectiveness of<br /><br>bevacizumab in the treatment of metastatic colon carcinoma:<br /><br>• Biological parameters.<br /><br>• 111In-bevacizumab distribution kinetics by gamma-camera imaging. Evaluation<br /><br>of gamma-camera imaging to recognize the distribution pattern of<br /><br>111In-bevacizumab in patients who do show response to bevacizumab therapy.</p><br>

Secondary Outcome Measures