A Phase 2b, 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 and Radiotherapy
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Oral Mucositis
- Sponsor
- SciClone Pharmaceuticals
- Enrollment
- 160
- Locations
- 49
- Primary Endpoint
- Efficacy
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a phase 2b, 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 (SCCs) 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB)
- •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
- •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
- •Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2)
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Have adequate hematopoietic, hepatic, and renal function at the screening visit:
- •Hematopoietic function
- •Hemoglobin ≥ 10 g/dL
- •Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3
- •Platelet count ≥ 100 × 109/L
Exclusion Criteria
- •Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor
- •Metastatic disease (M1) Stage IV C
- •Prior radiation to the head and neck
- •Plan to be treated with cetuximab (Erbitux®)
- •Have undergone induction CT
- •History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma
- •Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the study
- •Active infectious disease, excluding oral candidiasis
- •Have OM at the baseline visit
- •Have a diagnosis of autoimmune disease requiring chronic immunosuppression
Arms & Interventions
Placebo
Intervention: Placebo
SCV-07 0.1mg/kg
Intervention: SCV-07
SCV-07 0.3mg/kg
Intervention: SCV-07
SCV-07 1.0mg/kg
Intervention: SCV-07
Outcomes
Primary Outcomes
Efficacy
Time Frame: June 2012
The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT.
Secondary Outcomes
- Safety(June 2012)