Trial Details

A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB) Non-Small Cell Lung Cancer

NCT00055887

WITHDRAWN

DESCRIPTION

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as efaproxiral may make the tumor cells more sensitive to radiation therapy. It is not yet known if chemotherapy combined with radiation therapy is more effective with or without efaproxiral in treating non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy combined with radiation therapy with or without efaproxiral in treating patients who have stage III non-small cell lung cancer.

CONDITIONS

ELIGIBILITY CRITERIA

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed locally advanced, unresectable non-small cell lung cancer of 1 of the following subtypes:
• Adenocarcinoma
• Squamous cell carcinoma
• Large cell carcinoma
• Poorly differentiated carcinoma
• Stage IIIA or IIIB
• T1 or T2, N2
• T3, N1 or N2
• T4, any N
• Any T, N3
• Histological or cytological confirmation of at least 1 positive lymph node required if the largest mediastinal node that is the basis of stage III disease is less than 2.0 cm in diameter
• Clinically or radiologically measurable disease of at least 2.0 cm
• Partially resected stage IIIB disease allowed provided a measurable lesion remains
• No pleural effusion that is bloody, cytologically positive, or re-accumulated after thoracentesis
• No metastatic disease by CT scan or MRI PATIENT CHARACTERISTICS: Age
• 18 and over Performance status
• Karnofsky 70-100% Life expectancy
• Not specified Hematopoietic
• Hemoglobin at least 10 g/dL
• WBC at least 3,000/mm\^3
• Absolute granulocyte count at least 2,000/mm\^3
• Platelet count at least 100,000/mm\^3 Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• AST and ALT no greater than 2.5 times ULN Renal
• Creatinine no greater than 1.5 mg/dL Cardiovascular
• No clinically active congestive heart failure
• No unstable angina
• No severe arrhythmia by ECG Pulmonary
• FVC and FEV_1 at least 50% of normal
• Resting oxygen saturation by pulse oximetry (SpO_2) at least 90% on room air
• Exercise SpO_2 at least 90% on room air Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use effective contraception during and for 30 days after study therapy
• Male patients must use effective contraception during and for 90 days after study therapy
• No loss of more than 10% of body weight within the past 3 months
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No significantly altered mental status or dementia that would preclude giving informed consent
• No active infection
• No other serious underlying medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy
• More than 28 days since prior biologic therapy
• No concurrent colony-stimulating factors (randomized phase only)
• No biologic therapy during and for 1 month after study therapy
• No immune response modifiers during and for 1 month after study therapy Chemotherapy
• No prior systemic chemotherapy Endocrine therapy
• No hormonal therapy during and for 1 month after study therapy Radiotherapy
• No prior thoracic radiotherapy Surgery
• See Disease Characteristics
• No prior total surgical resection Other
• More than 28 days since prior investigational drugs or devices
• No prior efaproxiral
• No other cytotoxic therapy during and for 1 month after study therapy