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Title   A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to evaluate the efficacy and safety of three different doses of SCV-07 in attenuating oral mucositis in subjects with head and neck cancer receiving concurrent chemotherapy
Full Title   A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to evaluate the efficacy and safety of three different doses of SCV-07 in attenuating oral mucositis in subjects with head and neck cancer receiving concurrent chemotherapy
Disease/Condition   Head and Neck Cancer
Description   This is a phase 2, double-blind, placebo-controlled, 4-arm, adaptive design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject’s prescribed radiation plan, and Week 1 and Week 4 post-RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV-07 on the tumor response to ChemoRT. The primary efficacy endpoint is reduction in the proportion of subjects with clinically assessed ulcerative OM at a cumulative radiation dose of 45 Gy.
Eligibility Criteria   1. Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with
ChemoRT as first-line treatment; subjects with a history of surgical management are eligible
2. Have a plan to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single
daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site
receiving = 50 Gy
3. Have a plan to receive a standard cisplatin CT regimen administered triweekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2)
4. Have an Eastern Cooperative Oncology Group (ECOG) performance status= 2
5. Have adequate hematopoietic, hepatic, and renal function at the screening
Exclusion Criteria   1. Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
2. Metastatic disease (M1) Stage IV C
3. Prior radiation to the head and neck
4. Plan to be treated with cetuximab (Erbitux®)
5. Have undergone induction CT
6. History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma
Principal Investigator   Madhur Garg, MD
Contact Name   Hilda Haynes-Lewis, NP
Phone   (718) 920-8819
Contact Email   Hilda Haynes-Lewis, NP
Post Date   12/16/2011
Protocol Number   11-05-182
Inclusion/Notes   Medication
Status   Active
Adult Clinical Trial   No
Pediatric Clinical Trial   No