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

NCT ID: NCT00522249

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Carcinoma, Renal Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: EXPERIMENTAL

Pegylated Alfa Interferon

Intervention Type: DRUG

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.

sunitinib

Intervention Type: DRUG

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.

erlotinib

Intervention Type: DRUG

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.

Interventions

Pegylated Alfa Interferon

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.

Intervention Type: DRUG

sunitinib

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.

Intervention Type: DRUG

erlotinib

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.

Intervention Type: DRUG

Other Intervention Names

Intron A; PEG Intron®; PEG-Intron Redipen®; Sutent®; Tarceva®

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed metastatic or unresectable RCC. Patients must have a component of conventional clear cell renal carcinoma or papillary renal carcinoma.
• 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 disease.
• 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 eligible.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Amato, DO

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Baylor College of Medicine - Methodist Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

RCC-06-101

Identifier Type: OTHER

Identifier Source: secondary_id

PAC IRB#0806-0132

Identifier Type: -

Identifier Source: org_study_id