Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer

Stopped early · Phase 1

Conditions studied: Adenocarcinoma of the Lung, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer

In brief

Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib and radiation therapy with combination chemotherapy may kill more tumor cells. Phase I trial to study the effectiveness of combining erlotinib and radiation therapy with combination chemotherapy in treating patients who have inoperable stage III non-small cell lung cancer

Key facts

Study ID

NCT00042835

Run by

National Cancer Institute (NCI)

People needed

48

Starts

2002-05-01

Last updated by the study team

2013-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed non-small cell lung cancer
• Squamous cell carcinoma
• Adenocarcinoma (including bronchoalveolar)
• Large cell carcinoma (including giant and clear cell carcinomas)
• Stage IIIA (T1 or T2, N2) or IIIB disease not amenable to resection or surgery
• T3, N2 or T4, N0-N2 disease also allowed if based on the closeness to the carina, invasion of the mediastinum, or invasion of the chest wall
• T3, N0-N1 disease allowed provided the disease is not amenable for surgical resection
• No M1 disease
• No disease invasion of a vertebral body
• Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiotherapy boost field and there is no bone invasion
• Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiotherapy boost field
• Pleural effusion that is transudative, cytologically negative, and non-bloody allowed if the tumor can be encompassed in a reasonable field of radiotherapy
• No exudative, bloody, or cytologically malignant effusions
• Effusions present on CT scans but not on chest x-ray (CXR) and too small for thoracentesis are allowed
• Measurable or evaluable disease
• Pleural effusions are not considered measurable or evaluable
• Measurable disease is defined as any mass in 2 perpendicular diameters by CXR, CT scan, or MRI
• Evaluable disease includes lesions apparent on CXR or CT scan that are:
• Ill-defined masses associated with post-obstructive changes
• Mediastinal or hilar adenopathy measurable in only one dimension
• Performance status - ECOG 0-1
• Performance status - Karnofsky 70-100%
• More than 6 months
• WBC at least 3,000/mm\^3
• Absolute neutrophil count at least 1,500/mm\^3

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.