Clinical trial NCT00538772: An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Official title: An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carcinoma, Renal Cell
Keywords: Metastatic Renal Cell Carcinoma
Biomarkers
Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2007-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from Canadian centres who have agreed to participate in the trial entitled "A randomized trial of Temsirolimus and Sorafenib as second line therapy in patients with advanced renal cell carcinoma who have failed first line Sunitinib therapy" will be approached to participate in this Exploratory Biomarker study

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

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.

Primary outcomes:
measure: This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
timeFrame: Not available as study withdrawn on November 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: BC Cancer Agency - Centre for Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer Agency - Vancouver Island
state: British Columbia
Study officials:
affiliation: BC Cancer Agency- Vancouver
name: Christian Kollmannsberger, MD
role: PRINCIPAL_INVESTIGATOR
References: