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

NCT00759928 | Completed Phase 1

• 1 other identifier: SCRI LUN 175
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Refractory Solid Tumors

Keywords

Refractory Solid Tumors; Unresectable Stage III/IV; Sorafenib; Erlotinib; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• To evaluate safety of this combination in patients with Refractory Solid Tumors.

  3 months

Study Arms (1)

Erlotinib/Sorafenib

EXPERIMENTAL

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.

Drug: Erlotinib; Drug: Sorafenib

Interventions

Erlotinib DRUG

150 mg once daily by mouth

Also known as: Tarceva

Erlotinib/Sorafenib

Sorafenib DRUG

400 mg twice daily by mouth

Also known as: Nexavar

Erlotinib/Sorafenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with untreated brain metastases. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis. Patients who have a history of brain metastases that has been treated by surgery or radiation therapy \> 4 weeks with no signs of Central Nervous System (CNS) progression are allowed.
• Women who are pregnant or lactating.
• Patients whose last dose of chemotherapy, immunotherapy, or investigational drug therapy was completed \< 21 days prior to receiving study drug
• Significant cardiac disease within 90 days of starting study treatment including:
• superior vena cava syndrome;
• new onset angina;
• congestive heart failure (CHF) \> Class 2 per New York Heart Association (NYHA) classification (see Appendix B);
• ventricular arrhythmia;
• valvular heart disease.
• Myocardial infarction (MI) within 6 months prior to initiation of study treatment.
• Cardiomegaly on chest imaging or CHF \> Class 2 per NYHA classification (see Appendix B) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution within 3 months of initiating therapy.
• Poorly controlled hypertension (defined as systolic blood pressure \[BP\] \>150 mmHg and/or diastolic blood pressure \>90 mmHg on anti-hypertensive medications).
• Unstable angina (anginal symptoms at rest).
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
• Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Bayer: collaborator

Study Sites (2)

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

Erlotinib Hydrochloride; Sorafenib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• David R. Spigel, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: July 2, 2014

Record last verified: 2014-07

Locations

US (2)