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Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

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: NCT00529802
Recruitment Status : Completed
First Posted : September 14, 2007
Results First Posted : November 9, 2017
Last Update Posted : April 25, 2018
Information provided by (Responsible Party):
University of Chicago

September 12, 2007
September 14, 2007
October 27, 2016
November 9, 2017
April 25, 2018
September 2007
July 2010   (Final data collection date for primary outcome measure)
Relative Tumor Size Change Following 8 Weeks of Therapy. [ Time Frame: 8 weeks ]
The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.
if high uptake on FDG-PET is associated with tumor shrinkage
Complete list of historical versions of study NCT00529802 on Archive Site
Percent Change in FDG-PETUptake Following 2 Weeks of Therapy [ Time Frame: 2 weeks ]
The secondary objective was to explore whether an early change in FDG-PET uptake is associated with tumor shrinkage. Change in FDG-PET uptake was calculated using the baseline and 2-week FDG-PET scans.
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Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer
An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer
The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Renal Cell
Drug: RAD001
take 2 tablets of RAD001 once a day by mouth (10 mg per day)
Experimental: Everolimus (RAD001) 10mg daily
All patients were to receive 10mg everolimus (RAD001) daily.
Intervention: Drug: RAD001
Chen JL, Appelbaum DE, Kocherginsky M, Cowey CL, Rathmell WK, McDermott DF, Stadler WM. FDG-PET as a predictive biomarker for therapy with everolimus in metastatic renal cell cancer. Cancer Med. 2013 Aug;2(4):545-52. doi: 10.1002/cam4.102. Epub 2013 Jul 10.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2010
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Metastatic renal cancer refractory to sorafenib or sunitinib therapy
  • At least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
  • 18 years of age or older
  • Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy.
  • World Health Organization (WHO) performance status <= 2
  • Adequate bone marrow function
  • Adequate liver function
  • Adequate creatinine clearance
  • Signed informed consent

Exclusion Criteria:

  • Prior treatment with any investigational drug within the previous 4 weeks
  • Chronic treatment with systemic steroids or another immunosuppressive agent
  • Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
  • Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • A known history of HIV seropositivity
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
  • Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
  • Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment
  • Patients who have received prior treatment with an mTOR inhibitor.
  • Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
University of Chicago
University of Chicago
Principal Investigator: Walter Stadler, MD University of Chicago
University of Chicago
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP