Overview

This trial is active, not recruiting.

Conditions mucositis, head and neck cancer
Treatments placebo, palifermin, radiotherapy, cisplatin
Phase phase 1/phase 2
Sponsor Swedish Orphan Biovitrum
Collaborator Amgen
Start date July 2005
End date May 2007
Trial size 5 participants
Trial identifier NCT00626639, 20040124, NCT00963378

Summary

Oral Mucositis associated with adjuvant radiation and concurrent chemotherapy in postoperative Head and Neck setting

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose supportive care
Arm
(Placebo Comparator)
Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of matching placebo. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of matching placebo after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
placebo
Administered by intravenous (IV) bolus injection
radiotherapy
Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation [one fraction per day])
cisplatin
100 mg/m^2 intravenously (IV) on days 1, 22 and 43.
(Experimental)
Three days before the start of radiotherapy (Day -3), participants received a single intravenous (IV) bolus injection of palifermin at 120 μg/kg. During radiotherapy (beginning on Day 1), participants received a weekly single IV bolus injection of palifermin at 120 μg/kg after the last radiation fraction of that week (usually on Fridays) until grade ≥3 oral mucositis occurred, or for a maximum 8 doses (completion of radiotherapy). Participants also received cisplatin 100 mg/m^2 on days 1, 22 and 43.
palifermin
Administered by intravenous (IV) bolus injection
radiotherapy
Once daily irradiation of 20 centigray (cGy)/day x 33 fractions for a total target dose of 6600 cGy (conventional radiation therapy using standard fractionation [one fraction per day])
cisplatin
100 mg/m^2 intravenously (IV) on days 1, 22 and 43.

Primary Outcomes

Measure
Number of Participants With Adverse Events (AEs)
time frame: Up to Week 12 (or Week 15 for participants with severe OM was not resolved by Week 12)
Ratio of Ki67-positive Cells Before and After Palifermin Treatment
time frame: Day -3 predose and 24 or 48 hours post-dose
Pharmacokinetics of Palifermin
time frame: Day -3, predose and at 2, 5, 15, 30, 60, and 90 minutes and 2, 4, 6, 8, 10, 12, 24 and 48 hours after the first dose

Secondary Outcomes

Measure
Number of Participants With Severe Oral Mucositis (OM) (Adapted RTOG/EORTC Grade ≥3)
time frame: Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).
Patient-Reported Mouth and Throat Soreness Score
time frame: Assessed daily up to Week 12 (or Week 15 if severe oral mucositis not resolved ≤ adapted RTOG/EORTC Grade 2 by Week 12).
Number of Participants With Disease Progression by Week 12
time frame: Up to Week 12
Overall Survival
time frame: During long-term follow-up phase, until December 2015

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - History of newly diagnosed histologically confirmed squamous cell carcinoma (American Joint Committee on Cancer [AJCC] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1) - Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of surgery - High-risk subject defined by presence of at least one of the following: R1 resection margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; <3 lymph node metastases with extracapsular extension of the disease - Radiation treatment field to receive planned dose of at least 50Gy to areas of the oral cavity/oropharynx mucosa that can be visualized Exclusion Criteria: - Tumors of the lips, paranasal sinuses, salivary glands, or of unknown primary tumors - Metastatic disease (M1) / Stage IV C - Presence or history of any other primary malignancy - History of pancreatitis - Prior radiotherapy to the site of disease - Prior chemotherapy - Other investigational procedures - Thirty days or less since receiving an investigational product or device in another clinical trial. Current enrollment in another clinical trial is not permitted unless the sole purpose of the trial is for long-term follow-up/survival data

Additional Information

Official title A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Locally Advanced Head and Neck Cancer (HNC) Receiving Postoperative Radiotherapy With Concurrent Chemotherapy
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 bolus dose of palifermin or placebo at 120 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 January 2014.
Information provided to ClinicalTrials.gov by Swedish Orphan Biovitrum.