Palifermin in Lessening Oral Mucositis in Patients Undergoing Radiation Therapy and Chemotherapy for Locally Advanced Head and Neck Cancer

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Head and Neck Cancer, Mucositis, Pain, Radiation Toxicity

In brief

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.

Key facts

Study ID

NCT00360971

Run by

Radiation Therapy Oncology Group

People needed

21

Starts

2006-07-01

Expected to finish

2009-02-01

Last updated by the study team

2017-12-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;
• 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;
• 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.
• 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;
• Zubrod Performance Status 0-1;
• Age > 18;
• 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.)
• Adequate hepatic function with bilirubin < 1.5 mg/dl, AST or ALT < 2 x ULN within 2 weeks prior to registration;
• 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)
• 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);
• Serum pregnancy test for women of childbearing potential within 2 weeks prior to registration;
• Women of childbearing potential and male participants must practice adequate contraception.
• Patient agrees to refrain from using all products listed in Section 9.2, "Non-permitted Supportive Therapy";
• Patient must sign study specific informed consent prior to study entry.

You may not qualify if…

• Patients with a history of prior head and neck squamous cancer are ineligible;
• Stage IVC (AJCC, 6th edition) [Any T, Any N, M1] or distant metastases at protocol study entry; T1N1M0 patients are excluded.
• Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
• Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. See Sections 1 and 3.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
• Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.
• 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.
• Collagen vascular disease, such as scleroderma, as this disease is thought to predispose patients to increased risk for radiation-associated toxicities;
• Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin;
• 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®;
• 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.

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• Auburn Radiation Oncology — Auburn, California, United States
• Providence Saint Joseph Medical Center - Burbank — Burbank, California, United States
• Radiation Oncology Centers - Cameron Park — Cameron Park, California, United States
• Mercy Cancer Center at Mercy San Juan Medical Center — Carmichael, California, United States
• Enloe Cancer Center at Enloe Medical Center — Chico, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Radiation Oncology Center - Roseville — Roseville, California, United States
• Radiological Associates of Sacramento Medical Group, Incorporated — Sacramento, California, United States
• Mercy General Hospital — Sacramento, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Solano Radiation Oncology Center — Vacaville, California, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Saint John's Cancer Center at Saint John's Medical Center — Anderson, Indiana, United States
• St. Agnes Hospital Cancer Center — Baltimore, Maryland, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Dickinson County Healthcare System — Iron Mountain, Michigan, United States
• Borgess Medical Center — Kalamazoo, Michigan, United States
• West Michigan Cancer Center — Kalamazoo, Michigan, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• William Beaumont Hospital - Royal Oak Campus — Royal Oak, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• CentraCare Clinic - River Campus — Saint Cloud, Minnesota, United States
• Regional Cancer Center at Singing River Hospital — Pascagoula, Mississippi, United States

Full record on ClinicalTrials.gov

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