PK Trial of Sorafenib & Erlotinib in Patients With Refractory Solid Tumors

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00759928
Phase
PHASE1
Status
Completed

Conditions

  • Refractory Solid Tumors

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    150 mg once daily by mouth
  • Sorafenib — DRUG
    400 mg twice daily by mouth

Study Details

Two cohorts of patients will be enrolled: Cohort A will consist of patients who are current smokers, and Cohort B will consist of patients who are current nonsmokers. There will be 24 patients enrolled in each cohort. Nonsmokers are patients who have not consumed tobacco or nicotine-containing products for 1 year before the start of the study. Patients classified as current smokers must have smoked a minimum of 10 cigarettes per day for up to 1 year. Patients who have smoked 1-9 cigarettes per day for up to 1 year, or more than 10 cigarettes per day for less than 1 year will not be eligible for this study.

Key Dates

First listed
Sep 25, 2008
Start date
Oct 31, 2008
Status verified
Jul 2014
Primary completion
Sep 30, 2013
Completion
Jun 30, 2014

Study Design

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

Arms

  • Experimental: Erlotinib/Sorafenib
    Patients will receive erlotinib 150 mg once daily by mouth and sorafenib 400 mg twice daily by mouth. The study will begin with a 2-week run-in period (which will begin on Day 14 of the study, and continue through Day 1 of the study), in which erlotinib will be dosed alone at 150 mg once daily. Patients will continue taking erlotinib as a single agent at 150 mg once daily through Day 1. After the 2-week run-in period, patients will receive continuous dosing of both agents (erlotinib 150 mg once daily and sorafenib 400 mg twice daily) in cycles of 28 days each. Toxicity will be assessed every cycle (every 4 weeks) for all patients. Because this is not an efficacy study, restaging tumor measurements will be at the discretion of the physician every 8 weeks during treatment. Patients with objective response or stable disease will continue therapy; patients with disease progression or unacceptable toxicity will be discontinued from the study.

Primary Outcome Measure

To determine the pharmacokinetics (PK) of erlotinib when administered in combination with sorafenib on a continuous schedule in Refractory Solid Tumors in patients who are smokers and in patients who are nonsmokers. [ Time Frame: 3 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33916-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists· Fort Myers, FLTennessee Oncology· Nashville, TN

Related Studies