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

Sobi

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: Placebo; Drug: palifermin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00540332

20070201

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Palifermin

Experimental group

Description:

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.

Treatment:

Drug: palifermin