A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy, safety and tolerability of palifermin on the incidence of oral mucositis in subjects with locally advanced head and neck cancer receiving postoperative radiotherapy.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Approximately 17 subjects to receive palifermin. Subjects will be enrolled as follows:

* PK cohort will be randomized in a 3:1 ratio \[palifermin: placebo\] in at least 12 subjects
* Non-PK cohort will be randomized in a 1:1 ratio \[palifermin: placebo\] in up to 28 subjects.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.

Palifermin

Approximately 23 subjects to receive palifermin. Subjects will be enrolled as follows:

* PK cohort will be randomized in a 3:1 ratio \[palifermin: placebo\] in at least 12 subjects
* Non-PK cohort will be randomized in a 1:1 ratio \[palifermin: placebo\] in up to 28 subjects.

Group Type EXPERIMENTAL

palifermin

Intervention Type DRUG

120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course

Interventions

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Placebo

Single IV dose of placebo, 3 days before the start of RT, then once weekly placebo doses at the same dose during a planned 6 week RT course.

Intervention Type DRUG

palifermin

120μg/kg, single IV, 3 days before the start of Radiotherapy (RT), then once weekly at the same dose during a planned 6-week RT course

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC Stage II, III or IVA) involving either the oral cavity, oropharynx, hypopharynx, larynx and post surgical resection (R0 or R1)
* Candidates for postoperative RT-only treatment and scheduled to receive RT within 12 weeks of surgery
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Urinary protein-creatinine ratio (random sample, spot PCR) ≤ 0.2 mg/mg

Exclusion Criteria

* Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors and R2 resection margins
* Metastatic disease (M1)
* 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
* Prior radiotherapy to the site of disease
* Prior chemotherapy or requiring chemotherapy during treatment phase of study
* Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No