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Sunitinib and Erlotinib in Treating Patients With Unresectable or Metastatic Kidney Cancer

NCT00425386 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-05-03

Study results available
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Summary

RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer.

Conditions

Interventions

DRUG

erlotinib hydrochloride

Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily; 1. 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily; 2. 150 mg/day, continuous daily

DRUG

sunitinib malate

Will be administered at 50 mg daily, 4 weeks on, 2 weeks off

PROCEDURE

biopsy

Paraffin block (or unstained slides) of the primary tumor and/or metastatic lesions (as available) and a plasma sample for future correlative studies will be collected. A paraffin block (or at least 10 unstained slides, each of 10 micromillimeter thickness) from the original paraffin-embedded biopsy material taken at the diagnosis will be stored at 4 degrees Celsius.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Christopher W. Ryan, MD · OHSU Knight Cancer 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
2006-08-31
Primary Completion
2010-08-31
Completion
2014-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00425386 on ClinicalTrials.gov