A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy (RT/CT)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 315

Inclusion Criteria

- Histologically documented squamous cell carcinoma.
- Subjects with newly diagnosed (locally advanced) resected (R0, R1) HNC (American Joint Committee on Cancer [AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx and suitable to receive adjuvant concurrent RT/CT.
- Radiation treatment field to receive planned dose of at least 50 Gy to areas of the oral cavity / oropharynx mucosa that can be visualized by non-instrumental oral inspection.
- Subjects with larynx or hypopharynx tumors are eligible only if the radiation oncologist anticipates at least 2 of the 9 anatomical areas in the oral cavity [Mucositis Assessments] will receive a total dose of 50 Gy or more.
- Signed informed consent.
- Subject is 18 years of age or older.
- ECOG performance status (PS) less than or equal to 2.
- Planned interval < 6 calendar days between randomization and the first dose of RT.

Baseline laboratory assessments:
- Hemoglobin (Hgb) more than or equal to 10g/dL
- White blood count (WBC) > 3.5 x 10E9/L or
- Absolute neutrophil count (ANC) > 1.5 x 10E9/L.
- Platelet count more than or equal to 100 x 10E9/L.
- Serum bilirubin less than or equal to 1.5 x institutional upper limits of normal (ULN).
- Serum creatinine less than or equal to 2.0 mg/dL; Subjects with a serum creatinine more than or equal to 1.4 mg/dL and less than or equal to 2.0 mg/dL need to demonstrate a 24-hr urinary creatinine clearance more than or equal to 50 mL/min.
- Serum or urine pregnancy test: Negative
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors.
- Metastatic disease (M1) / Stage IV C.
- Presence or history of any other primary malignancy.
- History of pancreatitis.
- Prior radiotherapy to the site of disease.
- Prior chemotherapy.
- Other investigational procedures.
- Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data.
- Pregnant or breast-feeding women.
- Refusal to use adequate contraceptive devices during treatment phase.
- Known sensitivity to any of the products administered during dosing, including E coli-derived products.
- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Previous treatment on this study or with other keratinocyte growth factors.
- Compromised ability of the subject to give written informed consent and/or to comply with study procedures.
- Refusal to give written informed consent to participate in this study and to sign the hospital information release form.
- Unwilling or unable to complete the patient-reported outcome questionnaires.
- Psychological, social, familial, or geographical reasons that would prevent regular follow-up.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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