Status:
COMPLETED
Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney canc...
Detailed Description
Despite recent advances metastatic renal cell carcinoma remains an incurable condition. Currently available treatment with high-dose interleukin-2 can lead to complete responses in a small minority of...
Eligibility Criteria
Inclusion
- Signed informed consent to participate in this study.
- Histological diagnosis of renal cell carcinoma.
- Age greater or equal 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance status of 2 or better.
- Life expectancy of at least 3 months.
- Failure or intolerance to previous treatment with Sutent® and/or Nexavar®.
- Most recent systemic treatment at least 1 month from the beginning of treatment.
- Most recent local treatment (surgery or irradiation) \> 2 weeks from the beginning of treatment.
- At least one site of measurable disease by CT scan or MRI (RECIST criteria).
- Baseline hemoglobin \>9 g/dl, platelets \> 100,000/mm3, absolute neutrophil count (ANC \>1500/mm3.
Exclusion
- Previous treatment with Tarceva™, Iressa™, Rapamune™, temsirolimus or everolimus.
- Untreated metastasis to the central nervous system.
- Previous solid organ, bone marrow or stem-cell transplant.
- Known AIDS or HIV infection.
- Symptomatic or poorly controlled chronic heart failure.
- Chronic renal failure requiring dialysis on a regular basis.
- Chronic liver failure.
- Serum aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase or bilirubin \>1.5 x the upper limit of normal for the local laboratory.
- Pregnant or breast-feeding women.
- Other invasive malignant diseases within 5 years (other than squamous or basal cell carcinoma of the skin).
- Inability to provide informed consent
- Any other serious and/or unstable medical, psychiatric, or other condition considered by the P.I. to preclude safe or reasonably compliant participation in the protocol.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00353301
Start Date
July 1 2006
End Date
March 1 2012
Last Update
April 14 2014
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80010