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Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Kidney Cancer

Thank you

Trial Information

Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma


The drugs used in this trial are called targeted drugs as they target specific activities
that are carried out by cancer cells that make them grow and spread. Sorafenib is an
approved drug for the treatment of advanced kidney cancer. RAD001 is an experimental drug
that has been used in other research studies with other types of cancer. In this trial, the
use of RAD001 and sorafenib together for the treatment of kidney cancer is experimental. In
the Phase I portion of this study 13-16 patients will be treated with the same dose of
sorafenib and different doses of RAD001. The purpose is to see what is a safe dose of
RAD001 when combined with sorafenib in the treatment of kidney cancer. Once this dose of
RAD001 is determined, about 65 more patients will be treated to see how effective this
combination of drugs is against this kidney cancer.

Both of these drugs are taken by mouth. Sorafenib will be taken twice a day. RAD001 is
taken by mouth weekly. Patients will be able to continue treatment as long as their disease
does not worsen or side effects become intolerable.


Inclusion Criteria:



- Clinically documented metastatic or unresectable locally recurrent clear cell renal
carcinoma

- Previous removal of kidney except if the size of the tumor was less than 5 cm or
there was extensive liver or bone metastasis

- May have had no prior chemotherapy or up to 1 prior treatment regimen with
immunotherapy or chemotherapy

- Performance status of 0-1

- Measurable disease

- Adequate liver, renal, and bone marrow function

- Must be able to give written informed consent

- Women able to become pregnant must have a negative pregnancy test

- Must be 18 or over

- Must be able to swallow pills

Exclusion Criteria:

- Prior treatment with sorafenib or m-TOR inhibitors

- History of acute MI within the last 6 months

- Active brain metastasis or patients with meningeal metastases

- Prior treatment for another cancer in the last 5 years

- Prior bleeding problems; coughing up or vomiting blood

- Non-healing wounds, ulcer, or long bone fracture

- Chronic use of systemic steroids or immunosuppressive agents

- Uncontrolled hypertension

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have. You can then decide if you wish to
participate.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To define the optimal dose of RAD001 and sorafenib when used in combination

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

John D Hainsworth, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

SCRI GU 44

NCT ID:

NCT00392821

Start Date:

January 2007

Completion Date:

December 2013

Related Keywords:

  • Kidney Cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms

Name

Location

Florida Hospital Cancer InstituteOrlando, Florida  32804
Northeast Georgia Medical CenterGainesville, Georgia  30501
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Research Medical CenterKansas City, Missouri  64132
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Wellstar Cancer ResearchMarietta, Georgia  30060
Oncology Hematology CareCincinnati, Ohio  45242
Baptist Hospital EastLouisville, Kentucky  40207
Norton Cancer InstituteLouisville, Kentucky  40207
Hematology Oncology Associates of Northern NJMorristown, New Jersey  07960