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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Docetaxel; Erlotinib Hydrochloride; Etoposide; Etoposide phosphate; Paclitaxel

Criteria

Inclusion Criteria:

• 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

• Platelet count at least 100,000/mm^3

• Bilirubin normal

• AST and ALT no greater than 1.5 times upper limit of normal (ULN) and alkaline phosphatase normal

• AST and ALT normal and alkaline phosphatase no greater than 2.5 times ULN

• Creatinine normal

• Creatinine clearance at least 50 mL/min

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No history of cornea abnormalities (e.g., dry-eye syndrome, Sjögren's syndrome)

• No congenital abnormality (e.g., Fuch's dystrophy)

• No abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose)

• No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)

• No gastrointestinal tract disease resulting in the inability to take oral medications

• No required IV alimentation

• No peptic ulcer disease

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No history of allergy to compounds of similar chemical or biologic composition to erlotinib or other study agents

• No significant traumatic injury within the past 21 days

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No psychiatric illness or social situation that would preclude study compliance

• No other active malignancy within the past 6 months except non-melanoma skin cancer

• No concurrent colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) with radiotherapy

• No prior chemotherapy for lung cancer

• See Disease Characteristics

• No prior chest radiotherapy

• See Disease Characteristics

• At least 7 days since prior mediastinoscopy

• More than 3 weeks since prior formal exploratory thoracotomy

• More than 3 weeks since prior major surgery

• No prior surgical procedures affecting absorption

• No prior epidermal growth factor receptor-targeting therapies

• No other concurrent investigational or commercial agents or therapies directed at malignancy

• No concurrent combination antiretroviral therapy for HIV-positive patients