Pilot Study of Neo-Adjuvant Everolimus to Treat Advanced Renal Cell Carcinoma - Analysis of Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01107509
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : April 4, 2018
McMaster University
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Anil Kapoor, St. Joseph's Healthcare Hamilton

Brief Summary:
This study will gather data on potential biomarkers in the treatment of advanced renal cell carcinoma (kidney cancer) and investigate their use as indicators of disease response. The results could eventually enable doctors to match levels of therapy to levels of biomarker on an individual basis and to increase the chance of disease response in patients. This study will also test a new paradigm in the treatment approach of advanced kidney cancer by using the drug everolimus in a neo-adjuvant setting, with the overarching goal of decreasing cancer recurrence rates and improving patient outcomes and survival.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: everolimus Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Neo-Adjuvant Everolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy - Analysis of Serum and Tissue Biomarkers
Actual Study Start Date : October 1, 2010
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Arm Intervention/treatment
Experimental: Neo-adjuvant everolimus Drug: everolimus
10 mg/ day everolimus in the form of an oral tablet for 12 weeks leading up to nephrectomy (with a 1-week perioperative washout period) in patients with locally advanced disease and re-initiating the drug postoperatively in patients with metastatic disease for up to 24 months, or until disease progression. Dosage may be reduced at any point to 5 mg/ day in the event of any grade 3/ 4 toxicity.
Other Names:
  • Afinitor
  • RAD-001

Primary Outcome Measures :
  1. Response of primary tumor and metastases (if applicable) to everolimus in terms of tumor size and appearance (RECIST imaging response criteria) as determined by CT or MRI [ Time Frame: From 6 weeks after starting neo-adjuvant everolimus until 1 year post-nephrectomy (or up to 24 months post-nephrectomy in metastatic patients) ]

Secondary Outcome Measures :
  1. Effect of everolimus on blood and tissue biomarker expression (periodic blood testing and tissue samples from baseline renal biopsy and nephrectomy) in and among patients with locally advanced and metastatic disease with respect to baseline values [ Time Frame: From baseline to 1 year post-nephrectomy for blood biomarker levels and from baseline to nephrectomy (week 12) for tissue biomarker levels ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • At least 18 years of age and capable of giving informed consent
  • Radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T3b, T4, or any stage T with N1/ 2 and/ or metastatic disease
  • Having a nephrectomy and willing to have a kidney biopsy
  • ECOG score 0 or 1
  • Clear cell histology
  • Negative for HIV, Hepatitis B, and Hepatitis C
  • Negative pregnancy test for women of child-bearing potential

Exclusion Criteria:

  • Stage T1 disease without metastases
  • Abnormal laboratory values at screening within the following ranges:
  • Absolute neutrophil count ≤ 1.5 × 109/ L; Platelet count ≤ 100 × 109/ L
  • Leukocyte count ≤ 3 × 109/ L; Hemoglobin ≤ 80 g/ L; Serum creatinine ≥ 2.0 × the upper normal limit (UNL); Total bilirubin ≤ 1.5 × UNL; AST and ALT ≤ 3.0 × UNL
  • Fasting serum cholesterol ≤ 9.0 mmol/ L; Fasting serum triglycerides ≥ 5.0 mmol/L
  • Any major illness that, based on the investigator's judgment, will substantially increase the risk associated with a subject's participation in this study
  • Other currently active malignancies
  • Currently taking any medications known to interfere with the metabolism of everolimus
  • Receiving anticoagulation with warfarin
  • A history of pulmonary hypertension or interstitial lung disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01107509

Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
St. Joseph's Healthcare Hamilton
McMaster University
Novartis Pharmaceuticals
Principal Investigator: Anil Kapoor, MD, FRCSC McMaster University

Responsible Party: Anil Kapoor, MD, FRCSC, St. Joseph's Healthcare Hamilton Identifier: NCT01107509     History of Changes
Other Study ID Numbers: MIURCCEVERO
First Posted: April 21, 2010    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Keywords provided by Anil Kapoor, St. Joseph's Healthcare Hamilton:
Renal cell carcinoma
Locally advanced clear cell renal carcinoma
Metastatic clear cell renal carcinoma
Clear Cell Renal Carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents