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Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

This study is ongoing, but not recruiting participants.
OSI Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: January 24, 2008
Last updated: August 1, 2014
Last verified: August 2014

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Sorafenib and Erlotinib
Drug: Sorafenib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Sorafenib and Erlotinib or Sorafenib Alone in Patients With Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Median progression-free survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: March 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ARM A
Sorafenib and Erlotinib
Drug: Sorafenib and Erlotinib
Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
Other Name: Nexavar and Tarceva
Active Comparator: ARM B
Drug: Sorafenib
Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
Other Name: Nexavar


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically confirmed stage IIIB/IV or relapsed non-small cell lung carcinoma (squamous carcinoma, adenocarcinoma, or large cell carcinoma). Patients with mixed tumors with small-cell elements are ineligible.
  2. Patients with no more than 2 prior lines of therapy, with the latest of those therapies being single-agent erlotinib.
  3. Evidence of progressive disease on erlotinib as assessed by the treating physician. Erlotinib must be the last treatment for NSCLC prior to enrollment into this study. Patients may be on erlotinib until enrollment. If erlotinib has already been stopped, the period of time off Erlotinib cannot exceed 14 days prior to study enrollment.
  4. Patients must have experienced a clinical benefit (complete response [CR], partial response [PR], or stable disease [SD]) from prior therapy with erlotinib for a period of 8 weeks.
  5. Patient must have one measurable lesion measuring at least 10 mm in the longest diameter (LD) by spiral computed tomography (CT), or 20 mm with conventional techniques according to the Response Evaluation Criteria in Solid Tumors (RECIST).
  6. Recovery from any toxic effects of erlotinib to ≤ grade 1 per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
  7. Completion of palliative radiation therapy prior to the start of study treatment. Previously irradiated lesions in the advanced setting cannot be included as target lesions unless clear tumor progression has been observed following the completion of radiation therapy.
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  9. Absolute neutrophil count (ANC) >=1,500 and platelets >=75,000 (within 7 days prior to initial study treatment).
  10. Hemoglobin >=9 g/dL (within 7 days prior to initial treatment).
  11. International normalized ratio (INR) <=1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution if not on anticoagulation therapy. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate with the therapeutic range established prior to study treatment initiation.
  12. Serum creatinine <=1.5 x institutional upper limit of normal (ULN) within 7 days prior to initial study treatment. If the absolute value is greater than 2mg/dL, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >=45 mL/min to be eligible.
  13. Bilirubin <=1.5 x the ULN; transaminases <=3 x institutional ULN, except in known hepatic metastasis, wherein these may be >=5 x institutional ULN.
  14. Patients must be able to understand the nature of this study, give written informed consent, and comply with study requirements.
  15. Agreement of male patients (with partners of childbearing potential) and female patients of childbearing potential to use effective contraception to prevent pregnancy during treatment and for a minimum of 90 days thereafter. Additionally, women should not breastfeed during this time.

Exclusion Criteria:

  1. Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancers cured by local therapy alone, and a disease-free survival (DFS) >=3 years.
  2. Pregnancy or lactation. All females of child-bearing potential must have negative serum or urine pregnancy tests within 7 days prior to study treatment.
  3. Prior epithelial growth factor receptor (EGFR) inhibitors, with the exception of erlotinib, are not allowed. This includes both tyrosine kinase inhibitors (TKIs) and monoclonal antibodies. Prior vascular endothelial growth factor (VEGF) inhibitors, with the exception of bevacizumab, are not allowed.
  4. 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
    • arrhythmia
    • valvular heart disease.
  5. Myocardial infarction within 6 months prior to initiation of study treatment
  6. Cardiomegaly on chest imaging or ventricular hypertrophy on electrocardiogram (ECG) unless the left ventricular ejection fraction (LVEF) is within normal range for the institution.
  7. Poorly controlled hypertension (defined as systolic blood pressure [BP] >150 mm Hg and/or diastolic BP >100 mm Hg on antihypertensive medications).
  8. Unstable angina (anginal symptoms at rest).
  9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  10. Presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
  11. A serious active infection (> grade 2) at the time of treatment
  12. A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  13. Untreated brain metastases. Patients who have treated metastases >=4 weeks out (with surgery and/or radiation therapy) and no evidence of central nervous system (CNS) progression are eligible.
  14. Treatment with a non-approved or investigational drug within 28 days of initial study treatment.
  15. A major surgical procedure, open biopsy, or significant traumatic injury within 28 days of beginning treatment or anticipation of need for major surgery during the course of the study.
  16. Thrombolic or embolic events such as a stroke and transient ischemic attack (TIA) within the past 6 months.
  17. Any prior history of hypertensive crisis or hypertensive encephalopathy.
  18. Pulmonary hemorrhage/bleeding event >= grade 2 within 28 days of initial study treatment.
  19. Any other non-pulmonary hemorrhage/bleeding event >= grade 3 within 28 days of initial study treatment.
  20. Evidence or history of bleeding diathesis or coagulopathy.
  21. Serious non-healing wound, ulcer, or bone fracture.
  22. Use of St. John's Wort or rifampin (rifampicin).
  23. Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
  24. Any malabsorption problem.
  25. Any condition that impairs the patient's ability to swallow whole pills.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00609804

United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Wellstar Cancer Research
Marietta, Georgia, United States, 30060
United States, Indiana
Providence Medical Group
Terre Haute, Indiana, United States, 47802
United States, Kentucky
Norton Cancer Institute
Louisville, Kentucky, United States, 40207
United States, Louisiana
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, United States, 70806
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
National Capital Clinical Research Consortium
Bethesda, Maryland, United States, 20817
United States, Mississippi
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
United States, Missouri
St. Louis Cancer Care
Chesterfield, Missouri, United States, 63017
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Nebraska
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hematology-Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07960
United States, Tennessee
Associates in Hematology Oncology
Chattanooga, Tennessee, United States, 37404
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
OSI Pharmaceuticals
Study Chair: David Spigel, M.D. SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT00609804     History of Changes
Other Study ID Numbers: SCRI LUN 162
Study First Received: January 24, 2008
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Non-Small Cell Lung Cancer
Progressing on erlotinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 20, 2014