A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate theEfficacy and Safety of Weekly Doses of Palifermin (Recombinant HumanKeratinocyte Growth Factor, rHuKGF) for the Reduction of Oral Mucositis inSubjects With Advanced Head and Neck Cancer Receiving Radiotherapy WithConcurrent Chemotherapy (RT/CT). - Palifermin 2002402
- Conditions
- Mucositis associated with radiation therapy andconcurrent chemotherapy in subjects with HNC.MedDRA version: 14.0Level: HLTClassification code 10024530Term: Lip and oral cavity neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-000213-35-IT
- Lead Sponsor
- AMGEN S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 180
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 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
- Serum or urine pregnancy test: Negative
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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
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 followup/
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 coliderived
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
and Administration
? 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 patientreported
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