A study to evaluate the effects of palifermin in reducing mouth ulceration in subjects with locally advanced head and neck cancer
- Conditions
- Oral MucositisTherapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]MedDRA version: 18.0Level: LLTClassification code 10028130Term: Mucositis oralSystem Organ Class: 100000004856
- Registration Number
- EUCTR2004-001716-31-DE
- Lead Sponsor
- Swedish Orphan Biovitrum AB (publ.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
• Signed informed consent
• =18 years of age
• History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1) and candidates for adjuvant RT/CT
• High-risk subject defined by presence of at least one of the following: R1 resection margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; <3 lymph node metastases with extracapsular extension of the disease
• Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of surgery
• 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 a significant part of the oral mucosa to receive a total dose of 50Gy or
more.
• Karnofsky performance status = 70
• 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 109/L or absolute neutrophil count (ANC) > 1.5 x 109/L
- Platelet count = 100 x 109/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
- Females of childbearing potential: negative serum or urine pregnancy test
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 3
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
• 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 permitted unless the sole purpose of the trial is for long-term follow-up/survival data.
• 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