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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00538772
• Other study ID #: KNC-001
• Secondary ID: BiomarkersMetast
• Status: Withdrawn
• Start date: July 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2019
• Source: British Columbia Cancer Agency
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Other:
• Not applicable - blood tests/tissue specimen tests will be undertaken
Not applicable - blood tests/tissue specimen tests will be undertaken

Locations

Country	Name	City	State
Canada	BC Cancer Agency - Centre for Southern Interior	Kelowna	British Columbia
Canada	BC Cancer Agency - Vancouver	Vancouver	British Columbia
Canada	BC Cancer Agency - Vancouver Island	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Kim Chi	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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