A Phase 1 interventional study of carboplatin and paclitaxel albumin-stabilized nanoparticle formulation in Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx and Recurrent Squamous Cell Carcinoma of the Larynx, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by University of Chicago · Phase 1, Interventional, and Treatment
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.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when given in combination with FHX (5 fluorouracil [fluorouracil], hydroxyurea and twice daily radiation, in good induction responders) and of nab-paclitaxel added to hypofractionated radiotherapy for poor responders.
II. To explore the feasibility of a more rapid palliative chemoradiotherapy approach inpatients with refractory disease as demonstrated by failure to respond to initial chemotherapy.
III. To explore the role of induction chemotherapy as a predictive tool for definitive head and neck cancer management of previously treated patients.
SECONDARY OBJECTIVES:
I. Progression-free survival (PFS) (time to disease progression or death from any cause) on both study arms.
II. Overall survival and response rates in both arms.
TERTIARY OBJECTIVES:
I. To determine the correlation of secreted protein, acidic, cysteine-rich (SPARC) expression in head and neck cancer and response to therapy.
OUTLINE: This is a dose-escalation study of paclitaxel albumin-stabilized nanoparticle formulation.
RE-INDUCTION THERAPY (WEEKS 1-6): Patients receive paclitaxel albumin-stabilized nanoparticle formulation intravenously (IV) over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving good response undergo surgical resection and proceed to chemoradiation within 4-6 weeks.
AFHX REGIMEN: Patients achieving response to re-induction therapy receive hydroxyurea orally (PO) every 12 hours for 6 days (11 doses) beginning on day 0, fluorouracil IV continuously over 120 hours beginning on day 0, and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1. Patients also undergo radiation therapy twice daily (BID) on days 1-5. Courses repeat every 14 days for 5 weeks in the absence of disease progression or unacceptable toxicity.
PACLITAXEL + RADIATION (AXX) REGIMEN: Patients not achieving response to re-induction therapy receive paclitaxel albumin-stabilized nanoparticle formulation IV and undergo hypofractionated radiation therapy on day 1. Courses repeat every 7 days for 5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 2 years, every 6 months for 2 years, and then yearly thereafter.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 48 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Exclusion Criteria:
See Detailed Description
Drug: carboplatin · Drug: paclitaxel albumin-stabilized nanoparticle formulation · Drug: fluorouracil · Drug: hydroxyurea · Procedure: therapeutic conventional surgery · Radiation: radiation therapy · Radiation: hyperfractionated radiation therapy · Other: laboratory biomarker analysis
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel
Given IV
Also known as: 5-fluorouracil, 5-Fluracil, 5-FU
Given PO
Also known as: HU, HYD, Hydrea, Hydroxycarbamide, Hydurea
Undergo surgical resection
Undergo radiation therapy
Also known as: irradiation, radiotherapy, therapy, radiation
Undergo hyperfractionated radiation therapy
Correlative studies
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
Time frame: 4 weeks
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
Time frame: 4 weeks
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.
Time frame: The time from the date of registration to the date of progressive disease or death, assessed up to 1 year
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.
Time frame: The time from the date of registration to the date of death, assessed up to 1 year
Objective response rate (complete response [CR] + partial response [PR])
The objective response rate (CR + PR) and associated 90% confidence interval will be determined.
Time frame: Up to 1 year
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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