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 Radiotherapy With Concurrent Chemotherapy (RT/CT)
18 Years
N/A
Both
Mucositis, Solid Tumors, Stomatitis, Head and Neck Cancer, Squamous Cell Carcinoma
Trial Information
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 Radiotherapy With Concurrent Chemotherapy (RT/CT)
Key
Inclusion Criteria:
- Histologically documented squamous cell carcinoma involving either the oral cavity,
oropharynx, nasopharynx, hypopharynx, or larynx
- Newly diagnosed, locally advanced stage HNC (unresectable/unresected disease);
American Joint Committee on Cancer [AJCC] Stage III, IVA or IVB amenable to RT/CT as
the definitive treatment modality
- At least 50 Gy of radiation treatment to areas of the oral cavity/oropharynx mucosa
that can be visualized
- Concurrent chemotherapy regimen of Cisplatin 100mg/m2 on days 1, 22, and 43
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than or equal
to 2
- Adequate hematologic, renal and hepatic function
- Negative pregnancy test by serum or urine
- Signed informed consent
Key Exclusion Criteria:
- 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
greater than 3 years)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Incidence of severe (WHO Grade 3 or 4) oral mucositis within 12 weeks after start of radiotherapy with concurrent chemotherapy
Outcome Time Frame:
within 12 weeks after start of radiotherapy
Safety Issue:
No
Principal Investigator
MD
Investigator Role:
Study Director
Investigator Affiliation:
Amgen
Authority:
United States: Food and Drug Administration
Study ID:
20020402
NCT ID:
NCT00101582
Start Date:
August 2005
Completion Date:
February 2015
Related Keywords:
- Mucositis
- Solid Tumors
- Stomatitis
- Head and Neck Cancer
- Squamous Cell Carcinoma
- SCCHN
- Palifermin
- Mucositis
- Oral Cavity
- Oropharynx
- Nasopharynx
- Hypopharynx
- Larynx
- Mouth Pain
- Mouth Sores
- Radiation Therapy
- Radiotherapy
- Radiochemotherapy
- Concurrent Chemotherapy
- Xerostomia
- Stomatitis
- Mucosa
- KGF
- rHuKGF
- Keratinocyte Growth Factor
- HNC
- Head and Neck Cancer
- Oral Mucositis
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
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