Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer
NCT ID: NCT01847326
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2013-03-26
2024-01-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Abemaciclib + Nivolumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed or Recurred Within Six Months After Platinum-based Chemotherapy
NCT03655444
Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IV Head and Neck Cancer
NCT01711541
Chemotherapy and Locoregional Therapy Trial (Surgery or Radiation) for Patients With Head and Neck Cancer
NCT03107182
Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery
NCT02538510
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
NCT07195734
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
carboplatin
Given IV
paclitaxel albumin-stabilized nanoparticle formulation
Given IV
fluorouracil
Given IV
hydroxyurea
Given PO
therapeutic conventional surgery
Undergo surgical resection
radiation therapy
Undergo radiation therapy
hyperfractionated radiation therapy
Undergo hyperfractionated radiation therapy
laboratory biomarker analysis
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
carboplatin
Given IV
paclitaxel albumin-stabilized nanoparticle formulation
Given IV
fluorouracil
Given IV
hydroxyurea
Given PO
therapeutic conventional surgery
Undergo surgical resection
radiation therapy
Undergo radiation therapy
hyperfractionated radiation therapy
Undergo hyperfractionated radiation therapy
laboratory biomarker analysis
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
University of Chicago
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonas de Souza
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Comprehensive Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rosenberg AJ, Agrawal N, Pearson AT, Gooi Z, Blair E, Portugal L, Cursio JF, Juloori A, Chin J, Rouse K, Villaflor VM, Seiwert TY, Izumchenko E, Lingen MW, Haraf DJ, Vokes EE. Phase I study of nab-paclitaxel-based induction followed by nab-paclitaxel-based concurrent chemotherapy and re-irradiation in previously treated head and neck squamous cell carcinoma. Br J Cancer. 2022 Nov;127(8):1497-1506. doi: 10.1038/s41416-022-01941-0. Epub 2022 Aug 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2012-02179
Identifier Type: REGISTRY
Identifier Source: secondary_id
12-1554
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.