CompletedPhase 1/2

Neoadjuvant Chemoradiotherapy With or Without Gefitinib in Treating Patients With Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer

United StatesStarted 2003-05

Plain-language summary

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. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Who can participate

Age range19 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Stage IIIA (T1-3, N2) * Positive (pathological) ipsilateral mediastinal node * Selective stage IIIB meeting all of the following criteria: * No pleural/pericardial effusion or superior vena cava syndrome * T4 due to invasion of carina, trachea, or mediastinal structures * Mediastinal N3 nodes (without supraclavicular or cervical adenopathy) * Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration) * Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry * Measurable disease by contrast CT scan allowed * No bronchoalveolar cell carcinoma * No prior diagnosis of lung cancer PATIENT CHARACTERISTICS: Age * 19 and over Performance status * ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%) Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 150,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease Renal * Creatinine no greater than 1.4 mg/dL OR * Creatinine clear…

What they're measuring

Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.

Trial details

NCT IDNCT00062270

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2004-09