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An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

An Exploratory Study Evaluating FDG-PET as a Predictive Marker for mTOR Directed Therapy With RAD001 in Metastatic Renal Cell Cancer

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

Type of Study:


Study Design:

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

Outcome Measure:

to determine whether high uptake on FDG-PET is associated with tumor shrinkage

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Walter Stadler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

July 2010

Related Keywords:

  • Carcinoma, Renal Cell
  • metastatic
  • renal
  • cell
  • carcinoma
  • cancer
  • Carcinoma
  • Carcinoma, Renal Cell



Beth Israel Deaconess Med Ctr Boston, Massachusetts  02215
University of Chicago Chicago, Illinois  60637
Washington University St. Louis, Missouri  63110
Oncology/Hematology Associates Peoria, Illinois  61615
The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599