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

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT00522249
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

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

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
Aug 29, 2007
Start date
May 31, 2007
Status verified
Mar 2016
Primary completion
May 31, 2008
Completion
Jul 31, 2008

Study Design

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

Arms

  • Experimental: 1
    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.

Primary Outcome Measure

Time to progression Objective response rate [ Time Frame: every 6 wks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of Medicine - Methodist HospitalHoustonTexas77030-

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By research site
Baylor College of Medicine - Methodist Hospital· Houston, TX

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