EUCTR2005-006161-13-DE
Active, not recruiting
Not Applicable
A single arm Phase II study to assess efficacy and safety of bevacizumab in combination with the standard therapy (interferon alfa-2a and vinblastine) as first-line treatment for patients with metastatic renal cell cancer (Bevacizumab with standard therapy in RCC) - Bevacizumab with standard therapy in RCC
ConditionsMetastatic renal cell cancer
DrugsAvastin 25 mg/ml
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic renal cell cancer
- Sponsor
- Roche Pharma AG
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willingness to give written informed consent for study participation and for data protection (legal requirement in Germany: ‘Datenschutzrechtliche Einwilligung’).
- •Patient must be willing and able to comply with the protocol.
- •Patients with metastatic renal cell carcinoma of predominantly clear cell type with at least one measurable lesion according to RECIST criteria.
- •Patient was nephrectomized for primary clear cell renal cell carcinoma and postsurgical wound healing is completed..
- •Age \= 18 years.
- •ECOG Performance status \= 2\.
- •The required laboratory values at screening are as follows:
- •Hematology:
- •\- Absolute neutrophil count \= 1\.5 x 109/L
- •\- Platelet count \> 100 x 109/L.
Exclusion Criteria
- •Prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for RCC (including neo\-adjuvant or adjuvant therapy).
- •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- •Serious non\-healing wound, ulcer or bone fracture.
- •Evidence of bleeding diathesis or coagulopathy.
- •Hemapoetic diseases.
- •Serious dysfunction of bone marrow.
- •History or other evidence of ischemic retinopathy.
- •Uncontrolled thyroid disease.
- •Uncontrolled hypertension.
- •Contraindications of the standard therapy (interferon alfa\-2a and vinblastine).
Outcomes
Primary Outcomes
Not specified
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