MedTrace Logo

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

NCT00522249 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-03-17

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Robert J Amato, DO · The Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-05-31
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00522249 on ClinicalTrials.gov