Erlotinib and Sirolimus for the Treatment of Metastatic Renal Cell Carcinoma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT00353301
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib hydrochloride — DRUG
    Patients will receive single-agent Tarceva, 150 mg/day
  • Sirolimus — DRUG
    Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.

Study Details

The purpose of this study is to test the safety and efficacy of the combination of erlotinib hydrochloride (Tarceva™) and sirolimus (Rapamune™) in the treatment of patients with metastatic kidney cancer.

Key Dates

First listed
Jul 18, 2006
Start date
Jul 31, 2006
Status verified
Mar 2014
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: Erlotinib and Sirolimus
    Erlotinib hydrochloride (Tarceva) will be self-administered in an open-label unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent Tarceva, 150 mg/day. Sirolimus (Rapamune) will be self-administered in an open-label unblinded manner to all patients enrolled in the study. Patients will receive a loading dose of 6 mg of Rapamune seven days after beginning treatment with Tarceva™ followed by a dose of 2mg/day.

Primary Outcome Measure

Progression-free Survival [ Time Frame: Physical exam assessments were performed every 4 weeks during the treatment phase. Survival follow-up information was collected every 4 months following the termination visit until death, loss to follow-up, or study termination up to 275 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80010-

Find similar trials in Aurora, CO

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
University of Colorado Hospital· Aurora, CO

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