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Phase II Trial of Sorafenib With Concurrent Thoracic Radiotherapy for Poor Prognosis Non-Small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

Phase II Trial of Sorafenib With Concurrent Thoracic Radiotherapy for Poor Prognosis Non-Small Cell Lung Cancer (NSCLC)


The Study Drug:

Sorafenib is designed to block the function of important proteins in cancer cells. These
proteins, when active, are in part responsible for the growth and behavior of cancer cells.

Study Drug:

Up to 4 groups of 3-6 participants were to be enrolled in the Phase I portion of the study,
and up to 30 participants enrolled in Phase II. Phase II participants will receive
sorafenib at the highest dose tolerated in the Phase I portion.

All participants will receive the same type and amount of radiation.

Study Drug Administration:

Participants will take sorafenib capsules 1-2 times every day beginning on Day 1 of
radiation therapy. Participants will take the study drug 2 times a day. Participants will
take the study drug without food (1 hour before or 2 hours after eating).

Radiation Therapy:

Before receiving radiation therapy, the participant will have a "marking session". At this
visit, the participant will have a computed tomography (CT) scan that will be used to help
to plan out the radiation therapy. This will take about 45 minutes.

Before receiving radiation, the participant will also have a single photon computed
tomography (SPECT) scan of your lungs.

The participant will be given 15 radiation treatments, once a day, 5 days a week,
Monday-Friday. Each treatment will take about 30 minutes. He or she will sign a separate
consent form for radiation therapy and the procedure will be described in more detail.

Clinical Visits:

Participant will have routine clinical visits every week while receiving radiation therapy.
The information collected during these clinical visit will be used for the study. At these
visits, the following tests and procedures will be performed:

- Participant will have a physical exam, including measurement of your blood pressure and
weight.

- Participant will be asked about any side effects you may be experiencing and any new
drugs you may be taking.

- Participant will be asked how well you are able to perform the normal activities of
daily living (performance status evaluation)

- Blood (about 3-4 teaspoons) will be drawn for routine tests.

- Participant will have any tests that doctor feels medically necessary

Urine will be collected every week while taking sorafenib and receiving radiation therapy
for routine tests.

End-of-Study Visit:

Participant will have an end-of-study visit 4-6 weeks after Participant stops receiving
radiation. At this visit, Participant will have a CT scan to check the status of the
disease.

Follow-Up Visits:

Participant's first follow-up visit will be at 6 weeks (+/- 7 days) after radiation therapy
and the second follow-up appointment will be at 10 weeks (+/- 7 days) after radiation
therapy. Participant will then have follow up visits every 3 months. At these visits,
Participant will go though the following:

- A complete medical history will be recorded.

- Participant will have a physical exam, including measurement of your weight and blood
pressure.

- Participant will be asked how well you are able to perform the normal activities of
daily living (performance status evaluation).

- Participant will be asked about any drugs you may be taking.

- Blood (about 3-4 teaspoons) and urine will be collected for routine tests.

- Participant will also have chest x-ray.

- Participant will have a computed tomography (CT) scan of your chest area.

- The location, type, and size of all measurable lesions will be recorded.

- If your doctor thinks it is necessary, Participant will have a positron emission
tomography(PET)/CT scan.

- If doctor thinks it is necessary, Participant will have an electrocardiogram (ECG -- a
test that measures the electrical activity of the heart).

- Participant may have a lung perfusion scan to see if all regions of your lung are
equally functional or not. This is called lung SPECT scan.

- Participant will have a lung functional test (PFT) if your doctor thinks it is
necessary.

All these tests are routine examinations as he/she would have without participating in this
study in order to know the status of the disease.

This is an investigational study. Sorafenib is FDA approved and commercially available for
renal cell carcinoma. The radiation therapy schedule used for this study is standard
treatment for lung cancer patients. The use of sorafenib with radiation therapy is
investigational.


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
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
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. International Normalized Ratio (INR) < 1.5 or a Prothrombin time (PT)/Partial
Prothrombin time (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.

Exclusion Criteria:

1. Cardiac disease: Congestive heart failure > class II New York Hearth Association
(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 Computed Tomography (CT) scan/Magnetic Resonance Imaging (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 > Common Terminology Criteria for Adverse Events
(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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Complete or Partial Response at 6 Months

Outcome Description:

Efficacy of combination assessed by tumor response where tumor response is defined as > 60% complete or partial response rate at 6 months. Evaluation of target lesions where Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Outcome Time Frame:

Baseline to 6 Months

Safety Issue:

No

Principal Investigator

Zhongxing Liao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2007-0352 Phase II

NCT ID:

NCT01636921

Start Date:

January 2008

Completion Date:

January 2011

Related Keywords:

  • Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • NSCLC
  • Radiation Therapy
  • Sorafenib
  • BAY 43-9006
  • Thoracic Radiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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