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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Renal Cell

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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)

Safety Issue:

No

Principal Investigator

Anil Kapoor, MD, FRCSC

Investigator Role:

Principal Investigator

Investigator Affiliation:

McMaster University

Authority:

Canada: Health Canada

Study ID:

MIURCCEVERO

NCT ID:

NCT01107509

Start Date:

October 2010

Completion Date:

September 2012

Related Keywords:

  • Carcinoma, Renal Cell
  • Renal cell carcinoma
  • Metastatic
  • everolimus
  • neo-adjuvant
  • biomarkers
  • nephrectomy
  • Locally advanced clear cell renal carcinoma
  • Metastatic clear cell renal carcinoma
  • Clear Cell Renal Carcinoma
  • Carcinoma
  • Carcinoma, Renal Cell

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