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.
Brief Title
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
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Oral Mucositis
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
* Hepatic function
* Total bilirubin \< 1.5 times the upper-normal limit (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
* Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
* Have a negative serum pregnancy test if a woman is of childbearing potential
* Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
* Males or females aged 18 years or older.
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
* Known seropositivity for HIV, HBV, or HCV
* Prior use of SCV 07
* Have used any investigational agent within 30 days of randomization
* Are pregnant or breastfeeding
* Known allergies or intolerance to cisplatin
* Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments
* Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.
* 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
* Hepatic function
* Total bilirubin \< 1.5 times the upper-normal limit (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
* Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
* Have a negative serum pregnancy test if a woman is of childbearing potential
* Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
* Males or females aged 18 years or older.
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
* Known seropositivity for HIV, HBV, or HCV
* Prior use of SCV 07
* Have used any investigational agent within 30 days of randomization
* Are pregnant or breastfeeding
* Known allergies or intolerance to cisplatin
* Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments
* Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.
Inclusion 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
* Hepatic function
* Total bilirubin \< 1.5 times the upper-normal limit (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
* Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
* Have a negative serum pregnancy test if a woman is of childbearing potential
* Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
* Males or females aged 18 years or older.
* 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
* Hepatic function
* Total bilirubin \< 1.5 times the upper-normal limit (ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN
* Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min
* Have a negative serum pregnancy test if a woman is of childbearing potential
* Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential
* Males or females aged 18 years or older.
Gender
All
Gender Based
false
Keywords
Oral Mucositis
Head and Neck
Head and Neck Neoplasms
Mucositis
Stomatitis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
SCV-07
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01247246
Org Class
Industry
Org Full Name
SciClone Pharmaceuticals
Org Study Id
SCI-SCV-MUC-P2b-002
Overall Status
Unknown status
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Efficacy
Outcome Time Frame
June 2012
Secondary Outcomes
Outcome Description
The secondary objective of the study is to evaluate the safety and tolerability of SCV 07.
Outcome Time Frame
June 2012
Outcome Measure
Safety
See Also Links
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Madhur Garg
Investigator Email
mgarg@montefiore.org
Investigator Phone