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A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Carcinoma, Renal Cell

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Trial Information

A Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic Renal Cell Carcinoma

Over 75% of RCCs are highly vascularized tumors that overexpress a number of growth factors,
including VEGF, PDGF, and bFGF. In addition, RCC tumors overexpress the receptors for these
peptides. These ligands and receptors may be involved in the autocrine stimulation of tumor
cell growth, or in the paracrine stimulation of neovascular or stromal fibroblast growth
that supports tumor expansion. Novel treatment that specifically interrupts these signaling
pathways may have significant anti-tumor activity. When taken together, these data provide a
rationale for investigation of a combination therapy with PEG-Intron, Sunitinib and Tarceva
for clear cell and papillary RCC patients.

Inclusion Criteria:

- 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)
Investigational therapy

- 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

Exclusion Criteria:

- 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
are allowed.

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Time to progression Objective response rate

Outcome Time Frame:

every 6 wks

Safety Issue:


Principal Investigator

Robert J Amato, DO

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Methodist Hospital Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

July 2008

Related Keywords:

  • Carcinoma, Renal Cell
  • Metastatic Renal Cell Carcinoma
  • RCC
  • M3thodist
  • Pegylated Alfa Interferon
  • Sunitinib
  • Tarceva
  • Peg IFN
  • Carcinoma
  • Carcinoma, Renal Cell



The Methodist Hospital Research Institute Houston, Texas  77030