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A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva™ (Erlotinib Hydrochloride) and Rapamune™ (Sirolimus) in the Treatment of Metastatic Renal Cell Carcinoma.

Phase 2
18 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

A Phase II Single Arm Clinical Trial to Evaluate the Efficacy and Safety of the Combination of Tarceva™ (Erlotinib Hydrochloride) and Rapamune™ (Sirolimus) in the Treatment of Metastatic Renal Cell Carcinoma.

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 selected patients but is markedly toxic and not broadly available.
FDA-approved multikinase inhibitors (sorafenib and sunitinib malate) often cause partial and
transient tumor regression. There is no standard treatment metastatic renal cell carcinoma
for patients whose disease progressed on multikinase inhibitors. The kinase mammalian target
of rapamycin (mTOR) is overstimulated in a subset of renal cell carcinomas and other
malignancies and can be blocked by sirolimus leading to growth arrest. Erlotinib
hydrochloride is a drug that blocks the function of the epidermal growth factor receptor
(EGFR), often over expressed in kidney cancer. Sirolimus and EGFR inhibitors and been safely
used in combination. In vitro experiments show that erlotinib enhances the sirolimus induced
growth impairment in a panel of renal cell carcinoma cells. In the present study patients
with metastatic renal cell carcinoma whose disease progressed on multikinase inhibitors will
be treated with the combination of erlotinib hydrochloride (Tarceva™) and sirolimus
(Rapamune™). This is a single arm trial with no placebo or drug-based control arm

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

- 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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Description:

Time to progression is defined as the time from beginning of therapy until disease progression or death. For subjects who have not progressed at the time of statistical analysis, progression-free survival will be censored at the date of their last tumor assessment. Kaplan-Meier methods will be used to estimate median progression-free survival.

Outcome Time Frame:

Time from beginning of therapy until disease progression or death

Safety Issue:


Principal Investigator

Thomas W Flaig, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver


United States: Food and Drug Administration

Study ID:



Start Date:

July 2006

Completion Date:

March 2012

Related Keywords:

  • Renal Cell Carcinoma
  • Carcinoma, Renal Cell
  • Receptor, Epidermal Growth Factor
  • mTOR protein
  • Sirolimus
  • Erlotinib
  • Carcinoma
  • Carcinoma, Renal Cell



University of Colorado Hospital Denver, Colorado  80262