Head and Neck Cancer Clinical Trial
Official title:
LCCC 1330 - A Phase II Study of Weekly Carboplatin, Paclitaxel and Cetuximab for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Verified date | August 2020 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a non-randomized, open-label phase II trial of 38 patients with recurrent or metastatic SCCHN. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, paclitaxel and cetuximab. Following assessment of response, the treating physician at their discretion may continue to treat with weekly cetuximab as maintenance until disease progression. The study is designed to evaluate whether this regimen improves median overall survival (OS) as compared to an historical control population treated with a platinum plus 5-fluorouracil (5-FU). There is currently no agreed upon first line therapy for recurrent or metastatic SCCHN; regimen options are highly toxic, inconvenient and resource intensive. Our study regimen has been used extensively for induction therapy and off-protocol in palliative care, but treatment outcomes have yet to be defined by a clinical trial.
Status | Completed |
Enrollment | 14 |
Est. completion date | October 1, 2019 |
Est. primary completion date | October 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years old - Histologically or cytologically confirmed recurrent or metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN). All primary sites are eligible excluding WHO type III or EBV nasopharyngeal (WHO type I and WHO type II allowed as long as they are EBV negative) - ECOG performance status 0-1 - Adequate organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration: ANC greater than or equal to 1,500/mm3, Platelets greater than or equal to 100,000/mm3, HgB greater than 9g/dL (acceptable to reach this by transfusion), Total bilirubin less than or equal to 1.5mg/dL, Albumin greater than 2.5 g/dL, AST(SGOT)/ALT(SGPT) less than or equal to 2.5X institutional upper limit of normal, alkaline phosphatase less than or equal to 2.5 x upper limit of normal, GFR greater than 30 mL/min (by standard Cockroft and Gault formula or measured via 24 hour urine collection) - Women of childbearing potential (WOCBP) with negative serum or urine pregnancy test within 7 days of D1 of treatment - WOCBP and men must agree to use adequate contraception prior to study entry and for duration of treatment under this protocol; adequate contraception is defined as any medically recommended method (or combination of methods) per standard of care. - Cancer must be considered incurable by the treating clinician - Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: - History of prior cumulative exposure to > 300mg/m2 cisplatin, AUC of 18 of carboplatin, or their combined equivalent within one year prior to enrollment - Surgery or radiation within the four weeks prior to D1 of treatment under this protocol - Prior systemic chemotherapy unless it was part of definitive-intent (curative intent) treatment more than 6 months before study entry - Other active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusion - Pregnant or lactating female |
Country | Name | City | State |
---|---|---|---|
United States | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Bon Secours Virginia Health System | Midlothian | Virginia |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Median Overall Survival | Overall survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from D1 of treatment under this protocol until death as a result of any cause. | 36 months | |
Secondary | Median Progression Free Survival | Progression events will be defined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Progression free survival after treatment with weekly carboplatin, paclitaxel and cetuximab for 6 weeks with or without the addition of maintenance weekly cetuximab is defined as the time from Day 1 of treatment until progression or death as a result of any cause. | 36 months | |
Secondary | Overall Response Rate by Participants | Number of complete response (CR) and partial response (PR) after study treatment with weekly carboplatin, paclitaxel, and cetuximab for 6 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: CR is defined as disappearance of all target lesions; and PR as >=30% decrease in the sum of the longest diameter of target lesions | 6 weeks | |
Secondary | Incidence of Adverse Events | Grade 3 and 4 toxicities associated with this combined chemotherapy regimen as assessed by clinician assessment using the NCI Common Terminology Criteria for Adverse Events,a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of daily living (ADL). Grade 4 Life-threatening consequences; urgent intervention indicated. Describe patient reported symptoms associated with this regimen. | 18 weeks | |
Secondary | Head and Neck Quality of Life Assessments | Quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy - Head and Neck (FACT-HN) questionnaire. The FACT-HN is the FACT-General (FACT-G) and a head and neck cancer specific, 12 item subscale given at baseline, at end of treatment, and at first follow-up visit. The FACT-G is a 27 item measure of general QOL assessing function in 4 domains: physical well-being (PWB), social-family well-being (SFWB), emotional well-being (EWB) and functional well-being (FWB). Items are rated by patients on a Likert scale from 0 to 4, with all subscales summed to give a total score with a range of 0-148 Higher scores represent better QOL. | Baseline, End of treatment (EOT), First follow-up visit (8-12 weeks after EOT) |
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