Trial information
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
Status: Recruiting
Protocol number: ML19983
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study to assess the effect of first-line treatment with Avastin in combination with standard therapy on progression-free survival in patients with metastatic renal cell cancer.
Brief summary: This single arm study will assess the efficacy and safety of Avastin in combination with interferon alfa-2a and vinblastine as first line treatment in patients with metastatic renal cell cancer. Patients will receive Avastin (15mg/kg iv) every 3 weeks, interferon alfa-2a 3 times weekly (3 Mio IU sc escalating to 18 Mio sc) and vinblastine (0.1mg/kg iv) every 3 weeks. The anticipated time on study treatment is until tumor progression, and the target sample size is 100-500 individuals. Target sample size is
180.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Renal Cell Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Median progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Tumor assessment (RECIST criteria) Time frame: Event driven
2. AEs, laboratory parameters, vital signs. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- metastatic renal cell cancer of predominantly clear cell type;
- >=1 measurable lesion.
Exclusion criteria:
- prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for metastatic renal cell cancer;
- ongoing or recent need for full therapeutic dose of anticoagulants or chronic daily treatment with aspirin (>325mg/day);
- clinically significant cardiovascular disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 08/23/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Berlin
- Bonn
- Bremen
- Cottbus
- Darmstadt
- Dessau
- Düsseldorf
- Erlangen
- Frankfurt Am Main
- Göttingen
- Greifswald
- Halle
- Hannover
- Homburg
- Jena
- Kassel
- Kiel
- Leipzig
- Magdeburg
- Mainz
- Marburg
- München
- Neuss
- Rehling
- Stuttgart
- Ulm
- Villingen-Schwenningen
- Weiden
