The purpose of this study is to determine if palifermin will reduce the incidence of dysphagia in patients receiving concurrent chemoradiotherapy for treatment of Non-Small Cell Lung Cancer (NSCLC).

Condition	Treatment or Intervention	Phase
Carcinoma, Non-Small-Cell Lung Lung Cancer	Drug: palifermin	Phase II

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with a histologically or cytologically proven diagnosis of NSCLC
• Unresectable (locally advanced) stage IIIa or IIIb disease (Note: T3N1 and T4 are excluded.)
• RT field of treatment to encompass greater than or equal to 30% of esophageal region
• Life expectancy greater than or equal to 6 months
• Estimated weight loss less than or equal to 10% in the 3 months before study randomization
• Measurable disease
• 18 years of age or older
• ECOG performance status of 0 - 2
• Hemoglobin (hgb) greater than or equal to 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
• Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L without growth factor use in the 2 weeks before study randomization
• Platelet count greater than or equal to 100 x 10^9/L
• Serum bilirubin less than or equal to 1.5 x institutional upper limit of normal (ULN)
• Serum creatinine less than or equal to 2.0 mg/dL (Note: Subjects with a serum creatinine greater than or equal to 1.4 and less than or equal to 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance greater than or equal to 50 mL/min)
• Females of childbearing potential: negative serum or urine pregnancy test
• Subject must give written informed consent before participating in any study-specific procedure, randomization, or receiving investigational product.
• Subjects with reproductive capability must agree to practice adequate contraception methods.

Exclusion Criteria:

• Metastatic disease (M1)/stage 4 NSCLC
• T3N1 and T4 disease
• Plan to remove the tumor surgically before completing the protocol CT/RT course
• Shielding of any part of the esophagus during RT (including posterior spinal cord shielding)
• Prior chemotherapy, radiotherapy, or surgery for NSCLC
• Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Subjects with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before subject is randomized.
• Presence or history of dysphagia or conditions predisposing to dysphagia (eg, gastroesophageal reflux disease [GERD], dyspepsia, etc)
• History of pancreatitis
• Four weeks or less since completion of treatment using an investigational product/device in another clinical study.
• Previous treatment on this study or with a fibroblast growth factor
• Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
• Pregnant or breastfeeding women
• Known sensitivity to E coli derived products
• Compromised ability of the subject to give written informed consent and/or to comply with study procedures
• Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable
• Unwilling or unable to complete the PRO questionnaires
• Psychological, social, familial, or geographical reasons that would prevent regular follow-up

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Illinois
      Research Site, Park Ridge,  Illinois,  United States; Recruiting
Louisiana
      Research Site, Shreveport,  Louisiana,  United States; Recruiting
Maryland
      Research Site, Bethesda,  Maryland,  United States; Recruiting
New York
      Research Site, Brooklyn,  New York,  United States; Recruiting
      Research Site, Great Neck,  New York,  United States; Recruiting
South Carolina
      Research Site, Sumter,  South Carolina,  United States; Recruiting
Washington
      Research Site, Tacoma,  Washington,  United States; Recruiting

Study ID Numbers:  20030185
Record last reviewed:  February 2005
Last Updated:  February 14, 2005
Record first received:  October 27, 2004
ClinicalTrials.gov Identifier:  NCT00094861
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08