Clinical Trial: TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Study of TARCEVA (Erlotinib) in Combination With Chemoradiation in Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)

Brief Summary:

The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control Non-Small Cell Lung Cancer (NSCLC). The safety of this combination treatment will also be studied.

Researchers will also test the tissue from your earlier biopsy to measure the levels of epidermal growth factor receptor (EGFR). The purpose of EGFR testing is to learn about any link between various forms of EGFR and your response to treatment with erlotinib.

Primary Objective:

Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. Safety is measured by the rate of grade 3 or worse nonhematological toxicities occurring prior to the beginning of consolidation therapy (including all toxicities attributed to chemoradiation occurring within 90 days of the start of radiation therapy); compliance is defined as the completion of the treatment regimen with no more than minor variations.

Secondary Objectives:

  1. Investigate associations between EGFR expression and toxicity, response, overall survival, and progression
  2. Estimate overall survival of patients on the study regimen (one and two year rates, median survival).
  3. Estimate the time to disease progression of patients on the study regimen (one and two year rates)
  4. Estimate the treatment response rate of patients on the study regimen (complete and partial response rates)

Detailed Summary:

Erlotinib is designed to block the activity of a protein called epidermal growth factor (EGFR). EGFR is found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.

If you are found to be eligible to take part in this study, you will take erlotinib every day for 7 weeks (except on the days you receive chemotherapy). The erlotinib tablets should be taken at the same time each day, at least 1 hour before or 2 hours after a meal, with a small glass (about 7 ounces) of water. If you are unable to swallow tablets, you may dissolve the tablets in distilled water to drink.

You will receive radiation every day (Monday through Friday) for 7 weeks. You will also receive chemotherapy through a needle in a vein once a week for 7 weeks. The chemotherapy will include carboplatin and paclitaxel. Receiving chemotherapy will take about 6 hours total.

You will receive consolidation therapy on weeks 11-17.

Treatment on this study will last 17 weeks. Once a week during that time, you will have blood (about 2 tablespoons) drawn for routine tests. You will also have a CT scan of the chest within about 4 weeks from beginning the study, 2 months after finishing therapy, and then every 6 months after that for 2 years. The CT scans are used to check the status of the disease.

You will be taken off study if the disease gets worse or intolerable side effects occur. In this case, you would not receive erlotinib anymore but would continue standard chemotherapy and radiation therapy.

You will be asked to come in to the clinic for follow-up visits to check on your recovery from treatment. The follow-
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: Time to Disease Progression [ Time Frame: Up to 4 years ]

Time measured in months from treatment to disease progression, follow up every 6 months. Participants have a CT scan of the chest within about 4 weeks from beginning the study, 2 months after finishing therapy, and then every 6 months after that for 2 years. The CT scans are used to check the status of the disease.


Original Primary Outcome: Determine the feasibility of concurrent erlotinib and chemoradiation as measured by safety and compliance. [ Time Frame: 1.5 Years ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Investigate associations between EGFR expression and toxicity, response, overall survival, and progression. [ Time Frame: 1.5 Years ]
  • Estimate overall survival of patients on the study regimen (one and two year rates, median survival). [ Time Frame: 1.5 Years ]
  • Estimate the treatment response rate of patients on the study regimen (complete and partial response rates). [ Time Frame: 1.5 Years ]


Information By: M.D. Anderson Cancer Center

Dates:
Date Received: November 21, 2007
Date Started: November 2007
Date Completion: May 2019
Last Updated: April 26, 2017
Last Verified: April 2017