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

Carcinoma, Renal Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00522249
• Other study ID #: PAC IRB#0806-0132
• Secondary ID: RCC-06-101
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 27, 2007
• Last updated: March 15, 2016
• Start date: May 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2016
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-a) 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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell

Intervention

Drug:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine - Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital System	Schering-Plough

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression Objective response rate		every 6 wks	No
Secondary	Overall survival		every 6 weeks	No

External Links

•   click here for more information about the study.