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NCT00360971 · REGISTRY CONDITION SEARCH

Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for 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
TERMINATED
Registry last update
2017-12-26

RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.

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

Duration of Oral Mucositis as Measured in Terms of Days

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outcome · POSTED

Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale

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outcome · POSTED

Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale

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outcome · POSTED

Overall Survival

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Time to Second Primary Tumor

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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
Inclusion Criteria: 1. Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx; 2. Patients must have at least 2 mucosal sites of the oral cavity/oropharynx mucosa assessable by visual transoral inspection that will receive at least 66 Gy; -2.1 Patients with tumors of the larynx or hypolarynx are eligible only if it is anticipated that the 2 index sites in the oral cavity/oropharynx mucosa will receive at least 66 Gy; 3. Patients must be able to be evaluated for the primary endpoint; therefore, patients must be able to eat at least soft solids and not require a feeding tube for nutrition or hydration at study entry. 4. Selected Stage III (excluding T1N1MO) or IVA-B (AJCC, 6th edition) at study entry, including no distant metastases, based upon the following minimum diagnostic workup: * 4.1 History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to registration; * 4.2 Chest x-ray (or Chest CT scan) within 6 weeks prior to registration; * 4.3 MRI or CT scan with contrast of tumor site within 6 weeks prior to registration; * 4.4 Assessment of mucositis and xerostomia within 2 weeks prior to registration; 5. Zubrod Performance Status 0-1; 6. Age \> 18; 7. Adequate bone marrow function, defined as follows: * 7.1 Absolute neutrophil count (ANC) \> 1,800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study * 7.2 Platelets \> 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study * 7.3 Hemoglobin \> 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb \> 8.0 g/dl is acceptable.) 8. Adequate hepatic function with bilirubin \< 1.5 mg/dl, AST or ALT \< 2 x ULN within 2 weeks prior to registration; 9. Adequate renal function with serum creatinine \< 1.5 mg/dl and creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\]/\[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CrCl male) 10. Normal serum calcium or normal corrected serum calcium within 2 weeks prior to registration; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) = (4 - \[patient's albumin (g/dl)\] x 0.8) + patient's measured calcium (mg/dl); 11. Serum pregnancy test for women of childbearing potential within 2 weeks prior to registration; 12. Women of childbearing potential and male participants must practice adequate contraception. 13. Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy"; 14. Patient must sign study specific informed consent prior to study entry. Exclusion Criteria: 1. Patients with a history of prior head and neck squamous cancer are ineligible; 2. Stage IVC (AJCC, 6th edition) \[Any T, Any N, M1\] or distant metastases at protocol study entry; T1N1M0 patients are excluded. 3. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; 4. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. See Sections 1 and 3. 5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields; 6. Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted. 7. Severe, active co-morbidity, defined as follows: * 7.1 Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV (see Appendix II); * 7.2 Transmural myocardial infarction within the last 6 months; * 7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; * 7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. * 7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; * 7.6 Patients known to be sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV); * 7.7 Patients known to be sero-positive for human immunodeficiency virus (HIV) or patients with Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with HIV or AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. * 7.8 A history of pancreatitis. 8. Collagen vascular disease, such as scleroderma, as this disease is thought to predispose patients to increased risk for radiation-associated toxicities; 9. Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin; 10. Prior allergic reaction or known sensitivity to any of the agents administered during dosing, including E. coli-derived products, such as Nutropin®, Neupogen®, Humulin®, Roferon®; Neumega®, Neulasta®), IntronA®, Betaseron®; 11. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
    intervention Names
    1. Biological: palifermin
    2. Drug: cisplatin
    3. Procedure: neck dissection
    4. Radiation: radiation therapy
    label
    Palifermin
    type
    EXPERIMENTAL
  2. description
    Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
    intervention Names
    1. Drug: cisplatin
    2. Other: placebo
    3. Procedure: neck dissection
    4. Radiation: radiation therapy
    label
    Placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Palifermin
    description
    Four doses of palifermin, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
    name
    palifermin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Palifermin
    2. Placebo
    description
    Patients will receive cisplatin (100 mg/m2) administered intravenously on days 1, 22, and 43 of the treatment course.
    name
    cisplatin
    type
    DRUG
  3. arm Group Labels
    1. Placebo
    description
    Four doses of placebo, 180ųg/kg, administered as an i.v. bolus injection over 30-60 seconds. Starting on day -3 (Friday) prior to radiation therapy / chemotherapy and then once weekly, on days 5, 12, and 19.
    name
    placebo
    type
    OTHER
  4. arm Group Labels
    1. Palifermin
    2. Placebo
    description
    A neck dissection is required for patients with persistent nodal disease, any stage, if a palpable abnormality or worrisome radiographic abnormality persists in the neck 8-9 weeks after completion of therapy. A neck dissection is optional for patients with multiple positive lymph nodes or with lymph nodes exceeding 3 cm in diameter at pre-treatment (N2a, N2b, N3) who achieve a complete clinical and radiographic response in the neck. All patients will be assessed at approximately 8 weeks post-treatment with CT scan or MRI by the same technique used at baseline.
    name
    neck dissection
    type
    PROCEDURE
  5. arm Group Labels
    1. Palifermin
    2. Placebo
    description
    A radiation dose of 70 Gy with at least 66 Gy to at least 2 mucosal sites of the oral cavity/oropharynx mucosa. Radiation therapy can be given with 3D conformal (3D-CRT) or with intensity modulated RT (IMRT) techniques; however, the chosen modality must be used for the entire course of treatment.
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
21
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Duration in days of World Heath Organization (WHO) Grades 3 and 4 oral mucositis during the acute period (defined to be 105 days \[15 weeks\] or less from the start of treatment); duration is calculated from the onset of a Grade 3 or 4 oral mucositis to the day when an oral mucositis of ≤ Grade 2 is reported after the last oral mucositis of Grade 3 or 4. Patients with grade 0-2 mucositis have a duration of 0. This study required 298 patients to detect via two-sided t-test a reduction of mean duration of at least 9 days from 29 days (standard deviation = 23 days) on the placebo arm with 90% power and alpha = 0.05. Statistical testing was not done due to the small sample size.
    measure
    Duration of Oral Mucositis as Measured in Terms of Days
    time Frame
    Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
secondary Outcomes
  1. description
    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
    measure
    Number of Patients With Grade 3 or 4 Mucositis as Measured by the World Heath Organization (WHO) Scale
    time Frame
    Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
  2. description
    Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.
    measure
    Time to Onset of Grade 3 or 4 Oral Mucositis as Measured by the World Heath Organization (WHO) Scale
    time Frame
    Twice-weekly from start of treatment up to 15 weeks after the start of treatment.
  3. description
    An event is death from any cause. Overall survival was not calculated due to the limited number of events. Number of patients with an event is reported.
    measure
    Overall Survival
    time Frame
    From randomization to maximum follow-up at time of analysis of 21 months
  4. description
    An event is defined as the first occurrence of local, regional, distant disease. Progression-free survival is calculated at the time from registration to the death of progression, death in the absence of progression, or last follow-up. Progression-free survival was not calculated due to the limited number of events. Number of patients with an event is reported.
    measure
    Progression-free Survival
    time Frame
    From randomization to maximum follow-up at time of analysis of 21 months
  5. description
    An event is occurrence of a second primary other than basal cell. Time to second primary tumor was not calculated because there were no events. Number of patients with an event is reported.
    measure
    Time to Second Primary Tumor
    time Frame
    From randomization to maximum follow-up at time of analysis of 21 months
Full study description
brief Summary
RATIONALE: Growth factors, such as palifermin, may lessen the severity of mucositis, or mouth sores, in patients receiving radiation therapy and chemotherapy for head and neck cancer. It is not yet known whether palifermin is more effective than a placebo in lessening mucositis in patients receiving radiation therapy and chemotherapy for head and neck cancer. PURPOSE: This randomized phase III trial is studying palifermin to see how well it works compared to a placebo in lessening oral mucositis in patients undergoing radiation therapy and chemotherapy for locally advanced head and neck cancer.
detailed Description
OBJECTIVES: Primary * Compare the efficacy of palifermin vs placebo, in terms of burden of acute mucositis (defined to be 105 days \[15 weeks\] or less from the start of treatment), in patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx undergoing concurrent radiotherapy and chemotherapy. Secondary * Compare incidence and time to onset of Grades 3 or 4 oral mucositis in patients treated with these regimens. * Compare overall and progression-free survival and time to second primary in patients treated with these regimens. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease stage (III vs IVA or IVB), tumor site (oral cavity or oropharynx vs hypopharynx or larynx), and radiotherapy technique used on study (intensity-modulated radiotherapy \[IMRT\] vs 3-dimensional conformal radiotherapy \[3D-CRT\]). Patients are randomized to 1 of 2 treatment arms. Mucositis, pain, and symptom burden are assessed at baseline, during radiotherapy, and post radiotherapy. Xerostomia is assessed at baseline, during radiotherapy, and several times after completion of study therapy. After completion of study therapy, patients are followed periodically for 10 years. PROJECTED ACCRUAL: A total of 298 patients will be accrued for this study.
Source references
Source notices and limitations
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    Preserved source evidence · Not medical advice