Sorafenib and Thoracic Radiation for Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

The Phase II goal of this clinical research study is to find the efficacy of this combination assessed by tumor response and local progression failure.

Clinical Trial Description

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. ;

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

• NCT number: NCT01636921
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2008
• Completion date: January 2011