A Randomized, Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Palifermin (NSC# 740548; IND # 6370) for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Radiation Therapy With Concurrent Chemotherapy (Followed by Surgery for Selected Patients)
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 mucositis in patients treated with these
regimens.
- Compare symptom burden by patient-reported outcomes in patients treated with these
regimens.
- Compare experience of pain and opioid analgesic utilization in patients treated with
these regimens.
- Compare incidence of xerostomia in patients treated with these regimens.
- Correlate long-term effects of these regimens with disease outcome and survival of
these patients.
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.
All patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40,
and 42-46 (7 weeks for 3D-CRT) or days 1-5, 8-12, 15-19, 22-26, 29-33, 36-38, and 42-46 (7
weeks for IMRT). Patients also receive concurrent chemotherapy comprising cisplatin IV over
1-2 hours on days 1, 22, and 43 in the absence of disease progression or unacceptable
toxicity.
- Arm I: Patients receive palifermin IV on days -3, 5, 12, and 19. Patients who continue
to have ulcerative lesions after the completion of chemotherapy and radiotherapy
receive palifermin IV once weekly beginning on the last day of chemoradiotherapy and
continuing for up to 3 weeks.
- Arm II: Patients receive placebo IV on days -3, 5, 12, and 19. Patients who continue to
have ulcerative lesions at the completion of chemotherapy and radiotherapy receive
placebo IV once weekly beginning on the last day of chemoradiotherapy and continuing
for up to 3 weeks.
Patients are reevaluated 8 weeks after completion of chemoradiotherapy. Patients with
remaining tumor at that time may undergo a neck dissection and/or surgical resection of the
tumor.
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.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Duration of oral mucositis as measured in terms of days
From the start of treatment to 15 weeks
No
David I. Rosenthal, MD
Study Chair
M.D. Anderson Cancer Center
United States: Food and Drug Administration
RTOG-0435
NCT00360971
July 2006
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
Mount Nittany Medical Center | State College, Pennsylvania 16803 |
Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
Torrance Memorial Medical Center | Torrance, California 90505 |
William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Allegheny Cancer Center at Allegheny General Hospital | Pittsburgh, Pennsylvania 15212 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
Enloe Cancer Center at Enloe Medical Center | Chico, California 95926 |
Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
Mercy General Hospital | Sacramento, California 95819 |
Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden, New Jersey 08103 |
Auburn Radiation Oncology | Auburn, California 95603 |
Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
Radiation Oncology Center - Roseville | Roseville, California 95661 |
Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
Intercommunity Cancer Center | Monroeville, Pennsylvania 15146 |
Alle-Kiski Medical Center | Natrona Heights, Pennsylvania 15065 |
Somerset Oncology Center | Somerset, Pennsylvania 15501 |
Sharon Regional Cancer Care Center- Hermitage | Hermitage, Pennsylvania 16148 |
Johnson City Medical Center Hospital | Johnson City, Tennessee 37604 |