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

NCT00522249 | Terminated Phase 1

• 2 other identifiers: PAC IRB#0806-0132RCC-06-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Renal Cell

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to progression Objective response rate

  every 6 wks

Secondary Outcomes (1)

• Overall survival

  every 6 weeks

Study Arms (1)

1

EXPERIMENTAL

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.

Drug: Pegylated Alfa Interferon; Drug: sunitinib; Drug: erlotinib

Interventions

Pegylated Alfa Interferon 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.

Also known as: Intron A, PEG Intron®, PEG-Intron Redipen®

1

sunitinib 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.

Also known as: Sutent®

1

erlotinib 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.

Also known as: Tarceva®

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Schering-Plough: collaborator

Study Sites (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Introns; peginterferon alfa-2b; Sunitinib; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinazolines

Study Officials

• Robert J Amato, DO

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 29, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 17, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)