Text Size

Dosing and Effectiveness Study of Sorafenib and RAD001 in the Treatment of Patients With Advanced Kidney Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Novartis
Bayer
Information provided by (Responsible Party):
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00392821
First received: October 25, 2006
Last updated: December 12, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is being done in 2 parts. The first part is to determine the dose of RAD001 that should be used in combination with sorafenib. The second part is using the above determined dose of RAD001 in combination with sorafenib to see how effective these 2 drugs are against advanced kidney cancer.

Participants will be asked to keep a pill diary.


Condition Intervention Phase
Kidney Cancer
 Drug: Sorafenib
Drug: RAD001
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Sorafenib (Nexavar) and RAD001 (Everolimus)in the Treatment of Patients With Advanced Clear Cell Renal Cell Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • To define the optimal dose of RAD001 and sorafenib when used in combination [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • To evaluate the effectiveness of the drug combination [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To define overall tolerability and toxicity of the drug combination [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 81
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RAD001 and Sorafenib
 Drug: Sorafenib
Sorafenib
Other Name: Nexavar
Drug: RAD001
RAD001
Other Name: Everolimus, Zortress, Certican

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00392821

Locations
United States, Florida
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Kentucky
Baptist Hospital East
Louisville, Kentucky, United States, 40207
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, New Jersey
Hematology Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07960
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, South Carolina
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Tennessee
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
Sarah Cannon Research Institute
Novartis
Bayer
Investigators
Principal Investigator: John D Hainsworth, MD Sarah Cannon Research Institute
  More Information

No publications provided

Responsible Party: Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00392821     History of Changes
Other Study ID Numbers: SCRI GU 44, CRAD001C2480
Study First Received: October 25, 2006
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Everolimus
Sirolimus
 Sorafenib
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 13, 2013