NCT00101582 · REGISTRY CONDITION SEARCH

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2016-09-27

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Severe (Grade 3 or 4) Oral Mucositis

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outcome · POSTED

Duration of Severe (WHO Grade 3 or 4) Oral Mucositis

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outcome · POSTED

Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis

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outcome · POSTED

Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)

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outcome · POSTED

Patient-Reported Mouth and Throat Soreness Score

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outcome · POSTED

Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks

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outcome · POSTED

Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment

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outcome · POSTED

Number of Participants With Unplanned Breaks in Radiotherapy

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Drug: palifermin
Drug: cisplatin chemotherapy
Radiation: Radiotherapy
label
Palifermin
type
EXPERIMENTAL
description
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.
intervention Names
Drug: Placebo
Drug: cisplatin chemotherapy
Radiation: Radiotherapy
label
Placebo
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Placebo
name
Placebo
type
DRUG
arm Group Labels
Palifermin
name
palifermin
other Names
Kepivance
Recombinant Human Keratinocyte Growth Factor (rHuKGF)
type
DRUG
arm Group Labels
Palifermin
Placebo
description
Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m\^2 on Days 1, 22, and 43.
name
cisplatin chemotherapy
type
DRUG
arm Group Labels
Palifermin
Placebo
description
Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.
name
Radiotherapy
type
RADIATION

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: QUADRUPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 188
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral \& lateral tongue; left ventral \& lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.
measure
Number of Participants With Severe (Grade 3 or 4) Oral Mucositis
time Frame
Up to Week 15

secondary Outcomes

description
The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.
measure
Duration of Severe (WHO Grade 3 or 4) Oral Mucositis
time Frame
Up to 15 weeks
description
Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure. Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM.
measure
Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis
time Frame
Up to 15 weeks
description
The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.
measure
Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)
time Frame
Month 4
description
The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer \[OMWQ-HN\]): "How much mouth and throat soreness did you experience in the past 24 hours?" Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments.
measure
Patient-Reported Mouth and Throat Soreness Score
time Frame
Assessed twice a week for up to 15 weeks.
description
The total dose of opioid analgesics (mg of intravenous \[IV\] morphine equivalents) used by all participants. Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents.
measure
Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks
time Frame
Up to 15 weeks
description
Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason.
measure
Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment
time Frame
During the 7 weeks of chemotherapy treatment
description
Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy.
measure
Number of Participants With Unplanned Breaks in Radiotherapy
time Frame
During the 7 weeks of radiotherapy

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice