Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Genentech, Inc.
• Treatments: Erlotinib Hydrochloride; Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.