Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma

Completed · Phase 2

Conditions studied: Renal Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00353301

Run by

University of Colorado, Denver

People needed

25

Starts

2006-07-01

Expected to finish

2012-03-01

Last updated by the study team

2014-04-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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