Sorafenib and Thoracic Radiation for Patients With Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543335
Recruitment Status : Terminated (Lack of Accrual.)
First Posted : October 12, 2007
Last Update Posted : July 9, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to find the highest safe dose of sorafenib that can be given in combination with radiation therapy to people with lung cancer. The ability of both the study drug and radiation to control the disease will also be studied.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Sorafenib Procedure: Radiation Therapy Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of Sorafenib With Concurrent Thoracic Radiotherapy for Poor Prognosis Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : January 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Sorafenib + Radiation Therapy
Sorafenib starting dose 200 mg orally daily + 45 Gy total in 15 radiation treatments: 3 Gy per day, 5 days a week for 3 weeks
Drug: Sorafenib
Starting dose 200 mg PO (by mouth) Daily
Other Name: BAY 43-9006

Procedure: Radiation Therapy
45 Gy total in 15 radiation treatments: 3 Gy per day, 5 days a week for 3 weeks
Other Names:
  • RT
  • Radiotherapy

Primary Outcome Measures :
  1. Maximal tolerated dose (MTD) of sorafenib concurrent with thoracic radiation for poor prognosis NSCLC (phase I) [ Time Frame: Continual reassessment of safety throughout study and determination of dose-limiting toxicities during and at end of 3 week cycles. ]

Secondary Outcome Measures :
  1. Efficacy of combination assessed by tumor response and local progression failure (phase II) [ Time Frame: 6 Months and 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Pathologically proven previously untreated or systemically treated poor prognosis NSCLC patients for whom palliative thoracic irradiation is the treatment of choice per standard of care.
  2. Patients for whom palliative thoracic irradiation therapy to 45 Gy/15 FX is the recommended treatment by their treating radiation oncologist.
  3. The primary tumor and/or regional lymphatic metastases must be evaluable radiographically.
  4. Age >/= 18 years or older.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or greater, weight loss </= 30% or less.
  6. No prior radiation to the thorax.
  7. Adequate bone marrow, liver and renal function as assessed by the following: * Hemoglobin >/= 9.0 g/dl * Absolute neutrophil count (ANC) >/=1,000/mm^3 *Platelet count >/ =100,000/mm^3 * Total bilirubin </= 1.5 times ULN or greater * ALT and AST </= 2.5 times the ULN (</= 5 * ULN for patients with liver involvement) * Creatinine </= 1.5 * ULN
  8. Patients with distant metastasis are eligible.
  9. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  10. Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
  11. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  12. INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
  13. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of M.D. Anderson Cancer Center. The only approved consent form is attached to this protocol.

Exclusion Criteria:

  1. Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  2. Known hemorrhagic brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude hemorrhagic brain metastasis.
  3. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  4. Uncontrolled hypertension defined as systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  5. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  6. Active clinically serious infection > CTCAE Grade 3.
  7. Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  8. Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
  9. Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
  10. Serious non-healing wound, ulcer, or bone fracture.
  11. Evidence or history of bleeding diathesis or coagulopathy
  12. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  13. Current use of St. John's Wort or rifampin (rifampicin).
  14. Known or suspected allergy to sorafenib.
  15. Any malabsorption problem.
  16. Patients with squamous cell carcinoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543335

United States, Texas
UT MD . Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Zhongxing Liao, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00543335     History of Changes
Other Study ID Numbers: 2007-0352
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Non-Small Cell Lung Cancer
Lung Cancer
Radiation Therapy
BAY 43-9006
Thoracic Radiation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs