Phase 2
N=25
Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00353301 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Feb 2014
Primary outcome: Primary: Progression-free Survival — 12 Weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib hydrochloride (Drug); Sirolimus (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
12 | — |
| SECONDARY Overall Survival |
40 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00353301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.