Overview

This trial is active, not recruiting.

Conditions mucositis, solid tumors, stomatitis, head and neck cancer, squamous cell carcinoma
Treatments placebo, palifermin, cisplatin chemotherapy, radiotherapy
Phase phase 3
Sponsor Swedish Orphan Biovitrum
Collaborator Amgen
Start date August 2005
End date September 2007
Trial size 188 participants
Trial identifier NCT00101582, 20020402, NCT00963456

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
palifermin Kepivance
cisplatin chemotherapy
Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43.
radiotherapy
Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.
(Placebo Comparator)
Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
placebo
cisplatin chemotherapy
Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43.
radiotherapy
Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Primary Outcomes

Measure
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
time frame: Up to Week 15

Secondary Outcomes

Measure
Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
time frame: Up to 15 weeks
Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis
time frame: Up to 15 weeks
Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
time frame: Month 4
Patient-Reported Mouth and Throat Soreness Score
time frame: Assessed twice a week for up to 15 weeks.
Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
time frame: Up to 15 weeks
Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment
time frame: During the 7 weeks of chemotherapy treatment
Number of Participants With Unplanned Breaks in Radiotherapy
time frame: During the 7 weeks of radiotherapy

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Swedish Orphan Biovitrum.