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 Radiotherapy With Concurrent Chemotherapy (RT/CT)

Conditions: Oral mucositis
MedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oral

Registration Number: EUCTR2005-000213-35-HU

Lead Sponsor: Biovitrum AB (publ)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Key inclusion criteria
• Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
• Absence of second primary tumor confirmed by triple endoscopy or by pharyngo/laryngoscopy combined with imaging evidence (PET or CT scan or MRI)
• Newly diagnosed, locally advanced stage HNC (unresectable / unresected disease; American Joint Committee on Cancer [AJCC] Stage III, IVA, or IVB) amenable to RT/CT as the definitive treatment modality
• Radiation treatment field to receive planned dose of at least 50Gy to areas of the oral cavity / oropharynx mucosa that can be visualized
(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 listed in Section 7.4 of this protocol [Mucositis Assessments] will receive a total dose of 50 Gy).
• Signed informed consent
• Subject is 18 years of age or older
• ECOG performance status (PS) = 2
• Planned interval < 6 calendar days between randomization and the first dose of RT
Baseline laboratory assessments:
- Hemoglobin (Hgb) = 10g/dL
- White blood count (WBC) > 3.5 x 10e9/L or - Absolute neutrophil count (ANC) > 1.5 x 10e9/L
- Platelet count = 100 x 10e9/L
- Serum bilirubin = 1.5 x institutional upper limits of normal (ULN)
- Serum creatinine = 2.0 mg/dL; Subjects with a serum creatinine = 1.4 mg/dL and = 2.0 mg/dL need to demonstrate a 24-hr urinary creatinine clearance = 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

Key Exclusion Criteria:
• Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary
• Metastatic disease (M1) / Stage IV C
• Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer, or basal cell carcinoma of the skin without evidence of disease for > 3 years)
• History of pancreatitis
• Plan to remove the tumor surgically before completing the protocol RT / CT course
• 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.