Clinical trial NCT00101582: Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer
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 Radiotherapy With Concurrent Chemotherapy (RT/CT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mucositis
Solid Tumors
Stomatitis
Head and Neck Cancer
Squamous Cell Carcinoma
Keywords: 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
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2005-01-13
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to test the safety and effectiveness of palifermin to determine if weekly doses can be safely administered to reduce the incidence (occurrence of), duration (length of time) and severity (amount of pain) of oral mucositis (painful sores in the mouth). Mucositis is a common side effect for patients receiving chemotherapy (cancer-killing drug) and radiotherapy (cancer-killing x-rays) for the treatment of head and neck cancer (HNC).

Detailed description: This study consisted of 2 phases. The acute oral mucositis (OM) evaluation phase includes the time from randomization to the time of severe OM (WHO Grade 3 or 4) resolution (up to Week 12 or up to Week 15 for participants whose severe OM is not resolved at Week 12). In the acute OM evaluation phase, participants were randomized to receive either a single IV dose of palifermin or placebo at 180 μg/kg, 3 days before the start of radiotherapy, plus 7 once-weekly palifermin or placebo doses at the same dose level during a 7-week radio/chemotherapy course. In the long-term follow up phase, participants are followed until death, withdrawal of consent, or loss to follow-up. The long-term follow up phase is still ongoing.

Eligibility criteria: Key Inclusion Criteria:

* Histologically documented squamous cell carcinoma involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
* Newly diagnosed, locally advanced stage head and neck cancer (unresectable/unresected disease); American Joint Committee on Cancer \[AJCC\] Stage III, IVA or IVB amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality
* At least 50 Gray of radiation treatment to areas of the oral cavity/oropharynx mucosa that can be visualized
* Concurrent chemotherapy regimen of Cisplatin 100mg/m\^2 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)

Primary outcomes:
measure: Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
timeFrame: Up to Week 15
Secondary outcomes:
measure: Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
timeFrame: Up to 15 weeks
measure: Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis
timeFrame: Up to 15 weeks
measure: Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
timeFrame: Month 4
measure: Patient-Reported Mouth and Throat Soreness Score
timeFrame: Assessed twice a week for up to 15 weeks.
measure: Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
timeFrame: Up to 15 weeks
measure: Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment
timeFrame: During the 7 weeks of chemotherapy treatment
measure: Number of Participants With Unplanned Breaks in Radiotherapy
timeFrame: During the 7 weeks of radiotherapy
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: