Tongue Cancer Clinical Trial
Official title:
Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.
Verified date | January 2024 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | November 4, 2027 |
Est. primary completion date | November 4, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy - Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease - Prior radiation therapy completed >= 4 months, and/or chemotherapy completed >= 1 month before study entry, and patient should have recovered from any adverse effects - Predominance of disease that is amenable to radiotherapy - Measurable disease prior to induction chemotherapy - Eastern Cooperative Oncology Group performance status of one or less - Life expectancy of greater than 12 weeks - Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment - Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential - Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE]) - Leukocyte >= 3,000/ul - Absolute neutrophil count >= 1,500/ul - Platelets >= 1000,000/ul - Total bilirubin =< 1.5 x institutional upper limit of normal - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal - Creatinine clearance (CrCl) > 45 mL/min Exclusion Criteria: - Previously untreated patients with locoregional-only disease are not eligible - Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier - Patients may not be receiving any other investigational agents - History of allergic reactions attributed to compounds of similar chemical composition agents used in the study - Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function - Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0 | 4 weeks | ||
Primary | Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with radiation therapy, determined according to incidence of DLT graded using the NCI CTCAE 4.0 | 4 weeks | ||
Secondary | PFS | Statistical significance will be determined by a two-sided P value =< 0.05. Progression-free survival curves will be calculated using the Kaplan-Meier method, and median progression-free survival time, along with 90% confidence intervals will be derived using the procedure described in Brookmeyer and Crowley. | The time from the date of registration to the date of progressive disease or death, assessed up to 1 year | |
Secondary | Overall survival | Statistical significance will be determined by a two-sided P value =< 0.05. Overall survival curves will be calculated using the Kaplan-Meier method, and median overall survival time, along with 90% confidence intervals will be derived using the procedure described in Brookmeyer and Crowley. | The time from the date of registration to the date of death, assessed up to 1 year | |
Secondary | Objective response rate (complete response [CR] + partial response [PR]) | The objective response rate (CR + PR) and associated 90% confidence interval will be determined. | Up to 1 year |
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