Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Lung Neoplasms

Adenocarcinoma

Adenocarcinoma, Clear Cell

Adenomyoepithelioma

Carcinoma, Giant Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Epithelial-myoepithelial Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Oral Erlotinib 150 mg daily + Paclitaxel 45 mg/m\^2 by vein weekly + Carboplatin 2 AUC by vein weekly and Radiation Therapy 63 GY/35 fractions for 7 weeks cycles

Erlotinib

63 GY/35 fractions for 7 weeks (+/- 5 days)

Radiation Therapy

Steven H. Lin, MD, PHD

The goal of this clinical research study is to find out if erlotinib given with chemotherapy and radiation therapy can help to control 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.

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.

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a FEV1 (breathing test). You will have a complete physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Blood (about 2 tablespoons) will be drawn for routine tests. You will have a computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain to check the status of the disease. You will be required to have a positron emission tomography (PET) scan to locate the area of cancer outside the chest and lymph glands. You will have either a CT scan or an MRI to measure the size of the tumor(s). If there is positive finding of CT or MRI you will be taken off study. You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart). If you have a significant history of cardiovascular disease, you will have a MUGA scan and echocardiogram to test your heart function. Women who are able to have children must have a negative urine or blood (about 2 teaspoons) pregnancy test before starting treatment.

You will have PET scan 1 month after completion of consolidation chemotherapy.

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-up visits will be at the end of all treatment, 1 month after treatment, and then once a month for as long as your doctor feels it is necessary. Once your side effects have become less severe, you will be asked to come in to the clinic for follow-up visits every 3 months for 2 years, and then every 4 months for the following 2 years after that. You will have a physical exam, and your medical history will be recorded. You will be asked about any side effects you may have. Blood (about 2 tablespoons) will be drawn for routine tests. You will have a PET scan.

You have the right to leave the study at any time. If you choose to stop participating in this study, you should contact the study chair and/or research nurse. Your doctor may decide to take you off this study if your medical condition gets worse and/or you are unable to comply with study requirements.

At the end of the study you will not be automatically notified of the research findings. If you wish to learn about the results, however, you may request them from the study chair.

This is an investigational study. All three study drugs are commercially available. Carboplatin, and paclitaxel are FDA approved for the treatment of NSCLC, but their use in combination with erlotinib is not. Erlotinib is FDA approved for some uses, but it has not been approved by the FDA to treat lung cancer patients like yourself who have not yet undergone chemotherapy; however, the FDA has permitted its use in this research study. Carboplatin and paclitaxel are considered standard of care treatment and you would probably be treated with these drugs or similar drugs even if you decided not to be in the study. Up to 48 patients will take part in this study. All will be enrolled at M. D. Anderson.

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

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

Primary Endpoints is efficacy of concurrent erlotinib and chemoradiation as measured by time to progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions. All patients will be evaluated by followed up one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.

The Secondary Endpoints is Overall Survival (OS)and Disease Local Control (DLC)Rate. All patients will be followed up to evaluate Overall Survival and Disease Local Control by one month after treatment, once a month until recovery from treatment related toxicities, then every 3 months for 2 years, then every 4 months for 2 years (total of 4 years), then annually up to 5 years.

CT scan of the chest/upper abdomen, MRI of brain or CT, and/or PET scan images are recommended to confirm the recurrence.

Survival endpoints were estimated using the Kaplan-Meier method.

Genentech, Inc.

United States Department of Defense

M.D. Anderson Cancer Center

TARCEVA (erlotinib) 150 mg, P.O., daily, except for chemotherapy. Paclitaxel, 45mg/m2; Carboplatin, AUC=2, weekly; RT: 63Gy/35 fractions/7 weeks

Phase II TARCEVA (Erlotinib) With Chemoradiation in Stage IIIA

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Mexico

United Arab Emirates

Region of Enrollment

Disease Stage IIIA

Disease Stage IIIB

Tumor Histology Adenocarcinoma

Tumor Histology Squamous Cell Carcinoma

Tumor Histology NSCLC Unspecified

Karnofsky performance score (KPS) 100

Karnofsky performance (KPS) score 90

Karnofsky performance(KPS) score 80

EGFR status Wild-type

EGFR status- Mutated or deleted

EGFR status Unknown

Smoking history Former

Smoking history Current

Smoking history Never

Tumor HistologyLarge Cell Neuroendocrine Carcinoma

Disease stage by American Joint Committee on Cancer \[AJCC\] 6th Ed:

Stage IIIA: T1-3 N2 M0, Stage IIIB: T1-2 N3 M0 (contralateral mediastinal LN) or T4 Nx M0 (primary tumor involving mediastinal structures).

The earlier TNM staging, the better treatment outcome. The KPS:100 is "perfect" Normal health, 90 is able to carry on normal activity, minor signs or symptoms of disease, and 80 is normal activity with effort; some signs or symptoms of disease. The KPS was to allow physicians to evaluate a patient's survival. The higher KPS scores, the better treatment outcome.

Participants characteristic for completed treatment under the protocol and evaluable

48 patients registered and treated under the protocol.

Dr. Steven H. Lin/Radiation Oncology

There were 46 out of 48 patients completed treatment under the protocol and evaluable for data analysis. 2 patients cannot complete the treatment and off-study. 1 for diarrhea unrelated to treatment and the other for chemotherapy-induced chest pain.

Spots Global Cancer Trial Database for bronchoalveolar cell carcinoma