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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00538772
First received: September 28, 2007
Last updated: November 3, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention
Carcinoma, Renal Cell
Other: Not applicable - blood tests/tissue specimen tests will be undertaken

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made

Biospecimen Retention:   Samples With DNA

Approx. 40ml of blood for correlative studies will be drawn at predetermined time points: baseline, after cycle 1, at time of treatment failure/discontinuation of protocol therapy.

10 unstained slides from original patient specimen (nephrectomy specimens only) will be collected within 6 months after enrollment.


Estimated Enrollment: 50
Study Start Date: July 2008
Groups/Cohorts Assigned Interventions
Biomarker Other: Not applicable - blood tests/tissue specimen tests will be undertaken
Not applicable - blood tests/tissue specimen tests will be undertaken

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538772

Locations
Canada, British Columbia
BC Cancer Agency - Centre for Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, Canada, V8R 6V5
Sponsors and Collaborators
British Columbia Cancer Agency
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Christian Kollmannsberger, MD BC Cancer Agency- Vancouver
  More Information

No publications provided

Responsible Party: Dr Kim Chi, BC Cancer Agency -Vancouver Centre
ClinicalTrials.gov Identifier: NCT00538772     History of Changes
Other Study ID Numbers: KNC-001, Biomarkers, Metastatic Renal Cell
Study First Received: September 28, 2007
Last Updated: November 3, 2010
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
Metastatic Renal Cell Carcinoma
Biomarkers
Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014