An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma, Renal Cell
- Sponsor
- Kim Chi
- Locations
- 3
- Primary Endpoint
- This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
Purpose:
The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.
Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.
Detailed Description
It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression
Investigators
Kim Chi
Medical Oncologist
British Columbia Cancer Agency
Eligibility Criteria
Inclusion Criteria
- •All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.
- •Patients must provide written informed consent.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
Time Frame: Not available as study withdrawn on November 2010