Lung Cancer Clinical Trial
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)
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03918538 -
A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors
|
N/A | |
Recruiting |
NCT05078918 -
Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04548830 -
Safety of Lung Cryobiopsy in People With Cancer
|
Phase 2 | |
Completed |
NCT04633850 -
Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
|
||
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05898594 -
Lung Cancer Screening in High-risk Black Women
|
N/A | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03575793 -
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT01624090 -
Mithramycin for Lung, Esophagus, and Other Chest Cancers
|
Phase 2 | |
Terminated |
NCT03275688 -
NanoSpectrometer Biomarker Discovery and Confirmation Study
|
||
Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
Recruiting |
NCT06052449 -
Assessing Social Determinants of Health to Increase Cancer Screening
|
N/A | |
Recruiting |
NCT06010862 -
Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors
|
Phase 1 | |
Not yet recruiting |
NCT06017271 -
Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
|
||
Recruiting |
NCT05787522 -
Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk
|