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MucositisPhase 3NCT00101582

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

A Phase 3 study testing palifermin, cisplatin chemotherapy and Radiotherapy in people with Mucositis and Solid Tumors, run by Swedish Orphan Biovitrum.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucositis, Solid Tumors, Stomatitis
What is being tested?
palifermin, cisplatin chemotherapy and Radiotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
188 participants
Where
No sites listed yet
Study dates
Aug 2005to Aug 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

About this study

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)

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).

Read the 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.

Being tested
Placebo, palifermin, cisplatin chemotherapy, Radiotherapy
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
Medical subject headings
Mucositis, Stomatitis, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Laryngeal Diseases, Oral Ulcer, Xerostomia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

  • paliferminDrug

    Also called Kepivance, Recombinant Human Keratinocyte Growth Factor (rHuKGF)

  • cisplatin chemotherapyDrug

    Commercially available cisplatin was administered as an intravenous infusion at a dose of 100 mg/m^2 on Days 1, 22, and 43.

  • RadiotherapyRadiation

    Radiotherapy was delivered in 200 cGy daily fractions, 5 days a week.

Study groups in NCT00101582
Study groupRoleWhat they receive
PaliferminExperimentalParticipants 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.
Receives: Drug: palifermin; Drug: cisplatin chemotherapy; Radiation: Radiotherapy
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: cisplatin chemotherapy; Radiation: Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Up to Week 15

Secondary outcomes (7)

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

    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.

    Measured: Up to 15 weeks

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

    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.

    Measured: Up to 15 weeks

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

    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.

    Measured: Month 4

  4. Patient-Reported Mouth and Throat Soreness Score

    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.

    Measured: Assessed twice a week for up to 15 weeks.

  5. Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks

    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.

    Measured: Up to 15 weeks

  6. Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment

    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.

    Measured: During the 7 weeks of chemotherapy treatment

  7. Number of Participants With Unplanned Breaks in Radiotherapy

    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.

    Measured: During the 7 weeks of radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionSep 2007
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101582
Sponsor's protocol ID
20020402
Status last verified
Aug 2016
First submitted
12 Jan 2005
Last updated
27 Sep 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing palifermin, cisplatin chemotherapy and Radiotherapy in people with Mucositis and Solid Tumors, run by Swedish Orphan Biovitrum.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Severe (Grade 3 or 4) Oral Mucositis (time frame: Up to Week 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00101582.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.

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