Head and Neck Cancer Clinical Trial
Official title:
Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Verified date | March 2020 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth
in different ways. Some block the ability of tumor cells to grow and spread. Others find
tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy
uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with
cetuximab and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and
fluorouracil together with cetuximab and radiation therapy works in treating patients with
locally advanced head and neck cancer.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
Inclusion: - Histologically confirmed (from primary lesion and/or lymph nodes) squamous cell carcinoma (SCC) of the head and neck, including the following subtypes: - Oropharynx - Hypopharynx - Larynx - Primary site of tumor must not include any of the following: - Nasopharynx - Sinuses - Salivary glands - Stage III or IV disease that is unresectable (oropharynx, larynx, or hypopharynx) OR that is resectable with organ-sparing goal (oropharynx or hypopharynx) - Measurable disease by CT scan or MRI - No definitive evidence of distant metastasis - ECOG performance status 0-1 - ANC = 1,500/µL - Platelet count = 100,000/µL - Hemoglobin = 8 g/dL - Total bilirubin = normal - Except in the case where the elevated total bilirubin is not a sign of liver disease (i.e., Gilbert syndrome), in which case a total bilirubin = 2 times upper limit of normal (ULN) is allowed provided direct bilirubin is = ULN - AST, ALT, and alkaline phosphate (AP) meeting the following criteria: - AP normal AND AST or ALT = 5 times upper limit of normal (ULN) - AP = 2.5 times ULN AND AST or ALT = 1.5 times ULN - AP = 5 times ULN AND AST or ALT normal - Creatinine = 1.5 mg/dL - Negative pregnancy test (for women of childbearing potential) - Fertile patients must use effective contraception during and for = 3 months after completion of study treatment - Willing to undergo laryngoscopy with biopsy of residual tumor at primary site (as part of a comprehensive evaluation of tumor response after completion of the induction chemotherapy portion of study treatment) Exclusion: - History of severe hypersensitivity reaction to docetaxel or to other drugs formulated with polysorbate 80 - Other invasive malignancy within the past 3 years, except nonmelanoma skin cancer - Prior allergic reaction to the study drug(s) - Concurrent uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infection - Psychiatric illness/social situation that would limit compliance with study requirements - Significant history of uncontrolled cardiac disease, including any of the following: - Uncontrolled hypertension - Unstable angina - Myocardial infarction within the past 6 months - Uncontrolled congestive heart failure - Cardiomyopathy with decreased left ventricular ejection fraction (i.e., LVEF < 45%) - Uncontrolled condition that, in the opinion of the investigator, would interfere in the safe and timely completion of study procedures - History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan - HIV positivity - Pregnant or nursing - Prior chemotherapy for the study cancer - Prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields - Prior chemotherapy, biological therapy, or hormone therapy within the last one year - Prior initial surgical treatment, except diagnostic biopsy of the primary site or nodal sampling of neck disease - Prior radical or modified neck dissection - Prior therapy that specifically and directly targets the EGFR pathway - Concurrent investigational agents |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival | up to 2 years | ||
Secondary | Objective Response Rate | Will be measured by CT scan /MRI of the head and neck with corroborative results of direct biopsy of any residual tumor at primary site. | up to 2 years | |
Secondary | Best Overall Response Rate | Defined as rate of complete and partial responses (at least 30% decrease in the sum of the longest diameter of target lesions), measured by CT scan or MRI of the head and neck after completion of multimodality treatment with induction TPF (Docetaxel, cisplatin and fluorouracil) chemotherapy followed by combined ERT. We will use RECIST (Response Evaluation Criteria In Solid Tumors) (Therasse et al, 2000) for evaluation of response. | up to 2 years | |
Secondary | Overall Survival | up to 2 years | ||
Secondary | Number of Participants With Distant Metastasis | up to 2 years | ||
Secondary | Quality of Life - Functional Assessment of Cancer Therapy - General (FACT-G) | Four subscales: physical well-being (PWB; 7-items, score range 0-28), social/family well-being (SWB; 7-items, score range 0-28), emotional well-being (EWB; 6-items, score range 0-24), and functional well-being (FWB; 7-items, score range 0-28). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". Overall quality of life is the sum of the core items of the FACT-G possible range of 0-108 points. The higher the score the better the quality life. This interval includes 0, we will conclude that there is not conclusive statistical evidence that there is an improvement or worsening. If the interval does not include 0 we can determine whether there was a significant improvement (or worsening) depending on which side of the 0 the interval is on. The total outcome index score (possible range 0-108 points) is the sum of the physical and functional well being and additional concerns categories from the FACT-G. | Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years | |
Secondary | Number of Participants With Local-Regional Control | up to 2 years | ||
Secondary | Performance Status Scale for Head and Neck Cancer | Consists of assessment of three functions (subscales): Normalcy of diet, eating in public, and understandability of speech. The interviewer rates the patient on each scale based on the patient's responses to targeted questions. Scores range from 0-100 (Full performance (100 score), moderate or severe impairment (= 50 score)). The higher the score, the better the ability of the patient to function. | Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years | |
Secondary | MD Anderson Dysphagia Inventory | The MD Anderson Dysphasia Inventory (MDADI) is a survey specifically designed to assess dysphasia. It contains 20 questions directly addressing the swallowing function and several other general questions. The questionnaire asks for participants views about their swallowing ability at baseline, pre-radiation therapy and post-radiation therapy. All questions except for E7 and F2: Strongly Agree = 1 point, Agree = 2 points, No Opinion = 3 points, Disagree = 4 points, Strongly Disagree. E7 and F2: Strongly agree = 5 points, Agree = 4 points, no opinion = 3 points, disagree = 2 points, strongly disagree = 1 point. Scores range from 20 (extremely low-functioning) to 100 (high-functioning). | Baseline, pre-radiation therapy and post-radiation therapy, up to 2 years |
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