Renal Cell Carcinoma
Conditions
Brief summary
The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after institution of treatment.
Detailed description
* To explore if 89Zr-bevacizumab PET imaging can differentiate RCC patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus interferon. * To explore relationships between VEGF pathway related biomarkers and 89Zr-bevacizumab PET response. * To explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89Zr-bevacizumab PET response.
Interventions
At baseline, after two weeks of treatment and after 6 weeks of treatment.
Sponsors
Study design
Eligibility
Inclusion criteria
* locally advanced irresectable or metastatic renal cell cancer * no untreated brain metastases (CT or MRI not necessary in the absence of symptoms) * no uncontrolled hypertension * no clinically significant cardiovascular events or disease during the last 12 months * no surgery in the last 4 weeks * no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months * no treatment with a tyrosine kinase inhibitor during the last 4 weeks * measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray \> 20 mm, Spiral CT scan \> 10 mm, non-spiral CT scan \> 20 mm * clear cell histology component * not pregnant or nursing * women of childbearing potential must use effective contraception * absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * before patient randomization, written informed consent must be given according to GCP, and local regulations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in SUV between baseline 89Zr-bevacizumab PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib or bevacizumab plus interferon in patients with RCC. | after 2 and 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is defined as the appearance of new disease or an increase of 20% in the sum of the longest diameters of the target lesions. | 3 months after treatment |
Countries
Netherlands