A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer
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ClinicalTrials.gov Identifier: NCT00131638 |
Recruitment Status :
Completed
First Posted : August 19, 2005
Last Update Posted : December 16, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Drug: Placebo Drug: Palifermin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 241 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT) |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | November 2007 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Palifermin
Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course
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Drug: Palifermin
Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course
Other Name: KGF |
Placebo Comparator: Placebo
Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.
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Drug: Placebo
Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.
Other Name: Pbo |
- Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale) [ Time Frame: Up to 24 weeks ]
- Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck cancer [OMWQ-HN] [ Time Frame: 16 weeks ]
- Time to onset of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 12 weeks ]
- Total dose of opioid analgesics used (mg of morphine equivalents) [ Time Frame: 16 weeks ]
- Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT) [ Time Frame: 12 weeks ]
- Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher) [ Time Frame: 10 years ]
- Duration of severe oral mucositis (WHO Grades 3 or 4) [ Time Frame: 15 weeks ]
- Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT) [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- History of histologically documented squamous cell carcinoma ( AJCC [American Joint Committee on Cancer] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
- Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- Functional hematopoietic and hepato-renal systems
Exclusion Criteria:
- Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors
- 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)
- History of chronic pancreatitis or episode of acute pancreatitis within the last year
- Prior radiation to the site of the disease, or prior chemotherapy-

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131638
Study Director: | MD | Amgen |
Publications:
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT00131638 |
Other Study ID Numbers: |
20040118 |
First Posted: | August 19, 2005 Key Record Dates |
Last Update Posted: | December 16, 2016 |
Last Verified: | December 2016 |
Oncology KGF Palifermin Oral mucositis |
Clinical Trial Amgen head and neck |
Head and Neck Neoplasms Mucositis Stomatitis Neoplasms by Site Neoplasms |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Mouth Diseases Stomatognathic Diseases |