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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON30912

Enrollment

Registered

2007-08-10

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results