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Phase II Study of RAD001 (Everolimus) in Patient's With Metastatic Renal Cell Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

Phase II Study of RAD001 (Everolimus) in Patient's With Metastatic Renal Cell Cancer

Patients with metastatic renal cell cancer will be enrolled in the study if all eligibility
criteria are met and they agree to participate. The participant will take RAD001
(Everolimus) 10mg by mouth once a day. During the first cycle, they will have blood work
done once a week (4 weeks). On cycles thereafter they will have blood work on days 7 and
21. Once a month, the patient will have a chest x-ray. Every 8 weeks the patient will
have a CT scan of the chest, abdomen and pelvis. If clinically indicated, additional tests
will be done.

Inclusion Criteria:

- Patients must have predominantly clear cell renal cancer (75%)

- Patients must have evidence of metastatic disease. Metastatic disease should not be
progressing so as to require palliative treatment (e.g., radiation, surgery, etc),
within 4 weeks of enrollment.

- Patients may have received no more than two prior regimens such as immunotherapy,
chemotherapy or molecular targeted agents for renal cell carcinoma with at least 1
regimen consisting of a tyrosine kinase inhibitor (sorafenib or sunitinib). Four
weeks must have elapsed from previous therapy.

- Patients must have adequate physiologic reserves as evidenced by lab values

- Effective birth control must be practiced by both male and female patients

Exclusion Criteria:

- Patients with central nervous system metastases are excluded, except those patients
who have had complete excision or radiotherapy and remain asymptomatic, off steroids
for 21 days, with no evidence of new disease as shown by MRI

- Patients known to be HIV positive are not eligible, although testing specifically for
participation in this protocol is not required.

- Patients with a recent history of TIA (within 6 months), or are requiring regular
antianginal therapy or are having claudication sufficient to limit activity are not
eligible. Patients with a previous history of deep venous thrombosis or pulmonary
embolism are not eligible.

- Patients with active autoimmune disease.

- Patients who have had steroid therapy within the past three weeks.

- Patients involving concurrent anticancer drug therapy. Any immunosuppressive drugs
or any other experimental therapy.

- Female patients who are pregnant or lactating.

- The patient has an unstable medical condition, such as uncontrolled diabetes mellitus
or hypertension; active infections requiring systemic antibiotics, antivirals, or
antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not
limited to: unstable CHF; uncontrolled arrhythmias; unstable coagulation disorders;
or recent myocardial infarction (within 6 months).

- The patient has received any investigational agent(s) within 4 weeks of study entry.

- Patients with evidence of mucosal or internal bleeding and/or platelet refractory
(i.e., unable to maintain a platelet count > 50,000 cells/mm3).

- Patients unable to maintain an absolute neutrophil count (ANC) of < 1,500 cells/mm3.

- Any condition, including laboratory abnormalities, that in the opinion of the
Investigator places the patient at unacceptable risk if he/she were to participate in
the study.

- Prior malignancy (within the last 3 years) except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
patient has been disease-free for at least 3 years.

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 collect data on time to tumor progression produced by the study treatment.

Outcome Time Frame:

restaging every 8 weeks

Safety Issue:


Principal Investigator

Robert J Amato, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Methodist Hospital Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

October 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • metastatic kidney cancer
  • metastatic renal cell cancer
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



The Methodist Hospital Research Institute Houston, Texas  77030