A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy With Concurrent Chemotherapy
18 Years
N/A
Both
Mucositis, Head and Neck Cancer
Trial Information
A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy With Concurrent Chemotherapy
Inclusion Criteria:
- History of newly diagnosed histologically confirmed squamous cell carcinoma (AJCC
Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx,
nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1)
- Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of
surgery
- High-risk subject defined by presence of at least one of the following: R1 resection
margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; <3 lymph
node metastases with extracapsular extension of the disease
- Radiation treatment field to receive planned dose of at least 50Gy to areas of the
oral cavity/oropharynx mucosa that can be visualized
Exclusion Criteria:
- Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors
- Metastatic disease (M1) / Stage IV C
- Presence or history of any other primary malignancy
- History of pancreatitis
- 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 follow-up/survival data
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
To evaluate the safety and tolerability of palifermin when administered at the dose of 120 μg/kg weekly for up to 8 consecutive weeks.
Outcome Description:
To evaluate safety and tolerability of palifermin when administered at the dose of 120 μg/kg weekly for up to 8 consecutive weeks to patients with locally advanced head and neck cancer (HNC) receiving radiotherapy (RT) with concurrent chemotherapy (CT) as adjuvant treatment for their disease (post-operativ setting)
Outcome Time Frame:
by week 12 (or extended to week 15 if oral mucositis adapted RTOG/EORTC Grade ≥3 at week 12)
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
20040124
NCT ID:
NCT00626639
Start Date:
July 2005
Completion Date:
December 2015
Related Keywords:
- Mucositis
- Head and Neck Cancer
- palifermin
- Clinical Trial
- Oncology
- Head & Neck
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
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