Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

Sunitinib

Interferons

Peginterferon alfa-2b

Interferon-alpha

Interferon-alfa-1b

Erlotinib Hydrochloride

Antiviral Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Tyrosine

One cycle of the combination therapy will be 42 days (6 weeks). All patients will receive PEG-Intron given subcutaneously on Day 1 each week. Patients will receive Sunitinib orally on Days 1-28 of each cycle. Patients will receive Tarceva orally on Days 1-42.

Each patient will receive PEG-Intron administered subcutaneously one day per week of each 6 week cycle. The dose of PEG-Intron is determined based on the patient's weight and the dose level.

Pegylated Alfa Interferon

Patients will receive sunitinib orally as a single daily dose on Days 1-28 of each 42-day cycle. The dose will depend on the dose level.

sunitinib

Tarceva will be administered orally, 1-42 of each 42 day cycle. Dose will depend on dose level. Supplied as 150-mg, 100-mg and 25-mg strengths, white film-coated tablets for administration.

erlotinib

Robert J Amato, DO

The purpose of this study is to evaluate the combination of Pegylated Alfa Interferon (PEG-Intron), Sunitinib and Tarceva to see if this drug combination delays the disease progression of patients with metastatic Renal Cell Carcinoma. The first phase of this study will determine the best dose of Peg-Intron, Sunitinib and Tarceva when given in combination. The safety of giving these drugs in combination and response to treatment will also be examined.

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.

Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCC

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

Schering-Plough

The Methodist Hospital Research Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCC	NCT00522249	Carcinoma, Rena...	Pegylated Alfa ... sunitinib erlotinib	18 Years -	The Methodist Hospital Research Institute
Study of Pegylated Alfa Interferon, Sunitinib and Tarceva in Patients With Metastatic RCC	NCT00522249	Carcinoma, Rena...	Pegylated Alfa ... sunitinib erlotinib	18 Years -	The Methodist Hospital Research Institute

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