A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma
- Histologically or cytologically confirmed metastatic or unresectable RCC. Patients
must have a component of conventional clear cell renal carcinoma or papillary renal
- No more than three prior systemic therapies of any kind for RCC including: 1)
Immunotherapy (Adjuvant vaccines, Interleukin-2, Interferon-α) 2) Chemotherapy 3)
Molecular targeted agents (Nexavar [Sorafenib], Bevacizumab [Avastin]) 4)
- Patients with their primary tumor in place who are appropriate surgical candidates
should be strongly encouraged (but not required) to undergo nephrectomy.
- Prior palliative radiotherapy in metastatic lesion(s) is permitted, provided there is
at least one measurable and/or evaluable lesion(s) that has not been irradiated.
- All major surgery of any type and/or radiotherapy must be completed at least 4 weeks
prior to registration. Patients must have recovered from surgery and/or radiotherapy
toxicity prior to registration.
- At the time of enrollment, patients must have evidence of metastatic or unresectable
- Paraffin RCC tissue blocks or unstained slides must be obtained for future chemistry
staining or every effort made to obtain samples.
- Karnofsky performance status > 70%.
- Echocardiogram ejection fraction of ≥ 45%
- Age >18.
- Must meet required initial laboratory values
- Patients with true chromophobe, oncocytoma, collecting duct tumor and transitional
cell carcinoma are NOT eligible.
- Patients who have received small molecule epithelial growth factor inhibitors (such
as Irresa, Tarceva) are excluded.
- Patients who have had prior exposure to sunitinib are excluded.
- No ongoing hemoptysis, or cerebrovascular accident within 12 months, or peripheral
vascular disease with claudication on less than 1 block, or history of clinically
significant bleeding, because of the potential bleeding and/or clotting risk with
this combination therapy.
- No deep venous thrombosis or pulmonary embolus within 12 months of randomization and
no ongoing need for full-dose oral or parenteral anticoagulation. Low dose coumadin
(1 mg) for maintenance of catheter patency or daily prophylactic aspirin is allowed.
- No evidence of current central nervous system (CNS) metastases. Any imaging
abnormality indicative of CNS metastases will exclude the patient from the study.
- No significant cardiovascular disease defined as congestive heart failure (New York
Heart Association Class II, II or IV) angina pectoris requiring nitrate therapy, or
recent myocardial infarction (within the last 6 months).
- No active ischemia on electrocardiogram.
- No patients with uncontrolled hypertension (defined as blood pressure of > 160 mmHg
systolic and/or > 90 mmHg diastolic on medication).
- - Any ongoing requirement for systemic corticosteroid therapy (except replacement
therapy for adrenal insufficiency) is not permitted. Topical and/or inhaled steroids
- Patients with a pre-existing thyroid abnormality whose thyroid function cannot be
maintained in the normal range by medication are ineligible.
- No uncontrolled psychiatric disorder.
- Patients with delayed healing of wounds, ulcers, and/or bone fractures are not
- Patients with a 'currently active' second malignancy other than non-melanoma skin
cancers are not eligible.
- Pregnant women are excluded (negative urine or serum pregnancy test required) because
of the potential for teratogenic or abortifacient effects of therapy.