EUCTR2005-000213-35-IT进行中（未招募）不适用
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
AMGEN S.P.A.0 个研究点目标入组 180 人开始时间: 2006年11月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •? 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
排除标准
- •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
- •? 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
- •? 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.
研究者
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