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A Randomized, Phase III, Double-Blind, Placebo-Controlled Study
To Evaluate The Efficacy And Safety Of Palifermin (NSC# 740548;
IND #100,192) For The Reduction Of Oral Mucositis In Patients With
Locally Advanced Head And Neck Cancer Receiving Radiation Therapy
With Concurrent Chemotherapy (Followed by Surgery For Selected
Patients)
Pathologically proven (from primary lesion and/or lymph nodes)
diagnosis of squamous cell carcinoma of the oral cavity, oropharynx,
hypopharynx, or larynx; Patients must have at least 2 mucosal sites
of the oral cavity/oropharynx mucosa assessable by visual transoral
inspection that will receive at least 66 Gy; Patients with tumors
of the larynx or hypolarynx are eligible only if it is anticipated
that the 2 index sites in the oral cavity/oropharynx mucosa will
receive at least 66 Gy; Patients must be able to be evaluated for
the primary endpoint; therefore, patients must be able to eat at
least soft solids and not require a feeding tube for nutrition
or hydration at study entry; Zubrod Performance Status 0-1; Age
? 18; Adequate bone marrow, hepatic, and renal function as defined
in the protocol; Normal serum calcium or normal corrected serum
calcium within 2 weeks prior to registration; Patient agrees to
refrain from using all products listed in Section 9.2, "Non-permitted
Supportive Therapy"; Patient must sign study specific informed
consent prior to study entry; Patients with a history of prior
head and neck squamous cancer are ineligible; No Stage IVC or distant
metastases at protocol study entry (T1N1M0 patients excluded);
No prior invasive malignancy (except non-melanomatous skin cancer)
unless disease free for a minimum of 3 years; No prior systemic
chemotherapy for the study cancer; note that prior chemotherapy
for a different cancer is allowable. No prior radiotherapy to the
region of the study cancer that would result in overlap of radiation
therapy fields; Initial surgical treatment, excluding diagnostic
biopsy of the primary site or nodal sampling of neck disease; radical
or modified neck dissection is not permitted. No severe, active
co-morbidity as defined in the protocol; No collagen vascular disease;
No previous treatment with palifermin or other keratinocyte growth
factors; No prior allergic reaction or known sensitivity to any
of the agents administered during dosing, including E. coli-derived
products; No pregnancy; No women of childbearing potential and
men who are sexually active and not willing/able to use medically
acceptable forms of contraception.
For patients receiving concurrent RT/chemo
Arm 1: palifermin,
180 µg/kg
Arm 2: placebo
6-9 Weeks
Post-Treatment Reassessment: Required CT/MRI for
all patients
If suspicion of relapse: Directed biopsy
Selected Patients: Required Neck Dissection for
persistent nodal disease, butcomplete response of primary
298
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