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The Effect of Sorafenib (Nexavar®) on 111-Indium Labeled Chimeric Monoclonal Antibody G250 or 111-Indium Labeled Bevacizumab (Avastin®) Uptake in Patients With Clear Cell RCC (ccRCC)

18 Years
Open (Enrolling)
Clear Cell Renal Cell Carcinoma

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Trial Information

The Effect of Sorafenib (Nexavar®) on 111-Indium Labeled Chimeric Monoclonal Antibody G250 or 111-Indium Labeled Bevacizumab (Avastin®) Uptake in Patients With Clear Cell RCC (ccRCC)

Inclusion Criteria:

- Renal cell carcinoma patients planned for surgery (nephrectomy/metastasectomy)

- Karnofsky > 70 %

- Laboratory values within 14 days prior to start:

- White blood cells (WBC) > 3.5 x 109/L

- Platelets > 100 x 109/L

- Hemoglobin > 6 mmol/L

- Total bilirubin < 1.5 upper limit of normal (ULN)

- ASAT, ALAT < 2.5 x ULN (<5 x in case of liver metastases)

- Lactate dehydrogenase (LDH) > 1.5. ULN

- Serum creatinine < 2 x ULN

- Amylase and Lipase < 1.5 ULN

- Negative pregnancy test in premenopausal women

- Age over 18 years

- Signed informed consent

- Life expectancy > 24 weeks

- PT/APTT/ INR < 1.5 ULN

- No current use of coumarin derivatives

Exclusion Criteria:

- Known subtype other than clear cell RCC

- Pre-exposure to murine/chimeric antibody therapy

- Known brain metastases

- Untreated hypercalcemia

- Uncontrolled hypertension

- Concurrent therapeutic anticoagulation

- Chemotherapy, immunotherapy or radiation therapy within 4 weeks prior to start of
study. Palliative limited field external radiation for fracture prevention is allowed

- Cardiac arrhythmias requiring anti-arrythmics (beta-blockers, digoxin), symptomatic
coronary artery disease and congestive heart failure New York Heart Association III
or IV.

- Previous malignancy < 2 years prior to the study (except for cervical carcinoma in
situ, basal cell carcinoma, or superficial bladder tumours (Ta, Tis, T1)

- Any medical condition present that in the opinion of the investigator will affect
patients' clinical status. No other concurrent malignancy except nonmetastatic
nonmelanoma skin cancer or carcinoma in situ of the cervix.

- Active clinically serious bacterial or fungal infections (< grade 2 NCI-CTC version

- Known history of Human Immunodeficiency virus (HIV) infection or chronic hepatitis

- Prior use of Raf-kinase inhibitors, MEK and Farnesyl tranferase inhibitors

- Prior use of Bevacizumab and all other drugs that target VEGF/ VEGF-receptors

- Use of anti-epileptic drugs

- Pregnancy and lactation

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

To determine the effect of sorafenib treatment on 111In-cG250 uptake of the tumor

Outcome Time Frame:


Safety Issue:


Principal Investigator

WJG Oyen, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Nuclear Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

July 2007

Completion Date:

June 2012

Related Keywords:

  • Clear Cell Renal Cell Carcinoma
  • Angiogenesis inhibitors
  • Carcinoma
  • Carcinoma, Renal Cell