Study to Evaluate Palifermin in the Reduction of Dysphagia in Patients With Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Dysphagia; Non-Small Cell Lung Cancer; Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Deglutition Disorders
Intervention: Palifermin; Placebo; Radiotherapy; Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dysphagia; palifermin, KGF; chemoradiotherapy; NSCLC, non-small cell lung cancer; lung cancer; supportive care; clinical trial; consolidation chemotherapy; radiotherapy

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a histologically or cytologically proven diagnosis of NSCLC

          -  Unresectable (locally advanced) stage IIIa or IIIb disease

          -  Initial radiotherapy field of treatment to encompass greater than or equal to 30% of
             the esophagus

          -  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

          -  Eastern Cooperative Oncology Group (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: Patients 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

          -  Patient must give written informed consent before participating in any study-specific
             procedure, randomization, or receiving investigational product.

          -  Patients with reproductive capability must agree to practice adequate contraception
             methods.

        Exclusion Criteria:

          -  Metastatic disease (M1)/stage 4 NSCLC

          -  Pleural or pericardial effusion greater than 100 ml in volume as documented by
             appropriate imaging (positron emission tomography [PET], computed tomography [CT] scan
             or ultrasound). If an effusion greater than 100 ml is documented by cytology to be
             free from malignancy and the investigator feels the patient is capable of receiving
             chemo/radiotherapy for their primary disease/ NSCLC, the investigator should discuss
             the patient with the study physician at Amgen. Effusions smaller than 100 ml would be
             acceptable, unless the investigator suspects that the effusion is malignant, in which
             case the effusions should be evaluated by cytology. Sponsor approval must be obtained
             before patient is randomized.

          -  Plan to remove the tumor surgically before completing the protocol chemo/radiotherapy
             course

          -  Shielding of any part of the esophagus during radiotherapy (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: Patients 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 patient is randomized.

          -  Presence or history of dysphagia or conditions predisposing to dysphagia (eg,
             uncontrolled 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 or presence of any unresolved toxicity from
             previous treatment

          -  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 patient 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 patient reported outcome (PRO) questionnaires

          -  Psychological, social, familial, or geographical reasons that would prevent regular
             follow-up