An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

Withdrawn

• Conditions: Carcinoma, Renal Cell
• Interventions: Other: Not applicable - blood tests/tissue specimen tests will be undertaken

• Registration Number: NCT00538772
• Lead Sponsor: Kim Chi

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

Study Timeline

• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-03
• Study Start: 2008-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biomarker	Not applicable - blood tests/tissue specimen tests will be undertaken	-

Primary Outcome Measures

Name	Time	Method
This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made	Not available as study withdrawn on November 2010

Trial Locations

Locations (3)

BC Cancer Agency - Centre for Southern Interior; 🇨🇦 Kelowna, British Columbia, Canada

BC Cancer Agency - Vancouver Island; 🇨🇦 Victoria, British Columbia, Canada

BC Cancer Agency - Vancouver; 🇨🇦 Vancouver, British Columbia, Canada