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

This study has been terminated.
(Lack of Accrual.)
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00543335
First received: October 11, 2007
Last updated: July 5, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Lung Cancer
Drug: Sorafenib
Procedure: Radiation Therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy of combination assessed by tumor response and local progression failure (phase II) [ Time Frame: 6 Months and 12 Months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: January 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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.
  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 ClinicalTrials.gov identifier: NCT00543335

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00543335     History of Changes
Other Study ID Numbers: 2007-0352
Study First Received: October 11, 2007
Last Updated: July 5, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014