A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
18 Years
N/A
Both
Oral Mucositis, Head and Neck Cancer
Trial Information
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Safety and Efficacy of SC-07 for the Delay to Onset of Severe Oral Mucositis in Subjects Receiving Chemoradiation Therapy for the Treatment of Cancers of the Head and Neck.
Inclusion Criteria:
- Subject must have a body weight less than 150 kg at screening
- Have recently-diagnosed, pathologically-confirmed squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx that will be treated with chemoradiation
therapy as first line treatment(postoperative patients are eligible, if surgery is <
6 weeks prior to initiation of radiotherapy.
- Plan to receive a continuous course of conventional external beam irradiation
- Plan to receive a standard cisplatin chemotherapy regimen
Exclusion Criteria:
- Pregnant or breastfeeding
- Have head and neck tumors of the lips, sinuses, salivary glands or unknown primary
tumor
- Prior radiation to the head and neck
- Have a plan to receive cetuximab (Erbitux) in conjunction with chemotherapy
- Had curative surgery more than 6 weeks prior to the initiation of radiotherapy
- Have current oral mucositis
- Presence of active infectious disease excluding oral candidiasis
- Chronic immunosuppression
- Seropositive for HIV or hepatitis B surface antigen or C antibody
- Used an investigational agent within 30 days of randomization
- Have a known sensitivity to any investigational agent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research
Outcome Measure:
Safety will be assessed by collecting and recording AEs and laboratory assessments. Labs will be collected at screening,weekly throughout the subject's RT treatment and on the last day of radiotherapy.
Outcome Time Frame:
7 Weeks
Safety Issue:
Yes
Principal Investigator
Israel Rios, MD
Investigator Role:
Study Director
Investigator Affiliation:
SciClone Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
SCI-SCV-MUC-P2-001
NCT ID:
NCT00756951
Start Date:
September 2008
Completion Date:
Related Keywords:
- Oral Mucositis
- Head and Neck Cancer
- SCV-07
- Oral Mucositis
- Head and Neck Neoplasms
- Stomatitis
- Mucositis
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
| Whittingham Cancer Center | Norwalk, Connecticut 06856 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Beth Israel Medical Center | New York, New York 10003 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| University of Illinois at Chicago | Chicago, Illinois 60612 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| Temple University | Philadelphia, Pennsylvania 19140 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Ohio State University Medical Center | Columbus, Ohio 43210 |
| Mid Dakota Clinic | Bismarck, North Dakota 58501 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| The Nebraska Medical Center | Omaha, Nebraska 68198 |
| St Luke's Hospital & Health Network | Bethlehem, Pennsylvania 18015 |
| Helen F Graham Cancer Center | Newark, Delaware 19713 |
| Washington University in St Louis | St Louis, Missouri 63110 |
