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

Part of paid clinical trials in Los Angeles, California.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT00425386
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
    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
  • sunitinib malate — DRUG
    Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
  • biopsy — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jan 23, 2007
Start date
Aug 31, 2006
Status verified
May 2017
Primary completion
Aug 31, 2010
Completion
Mar 31, 2014

Study Design

Enrollment
60 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib and Sunitinib
    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

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib. [ Time Frame: Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
OHSU Knight Cancer InstitutePortlandOregon97239-3098-
Providence Cancer Center at Providence Portland Medical CenterPortlandOregon97213-2967-
Salem HospitalSalemOregon97301-

Find similar trials in Los Angeles, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
University of Southern California· Los Angeles, CAOHSU Knight Cancer Institute· Portland, ORProvidence Cancer Center at Providence Portland Medical Center· Portland, ORSalem Hospital· Salem, OR

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