Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Carboplatin Followed By Chemoradiation in Treating Patients With Recurrent Head and Neck Cancer

NCT01847326 | Completed Phase 1

• 2 other identifiers: 12-1554NCI-2012-02179
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Tongue Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• PFS

  The time from the date of registration to the date of progressive disease or death, assessed up to 1 year

• Overall survival

  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])

  Up to 1 year

Study Arms (1)

Treatment (induction therapy and AFHX or AXX)

EXPERIMENTAL

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

Interventions

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Treatment (induction therapy and AFHX or AXX)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Given IV

Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel

Treatment (induction therapy and AFHX or AXX)

fluorouracil DRUG

Given IV

Also known as: 5-fluorouracil, 5-Fluracil, 5-FU

Treatment (induction therapy and AFHX or AXX)

hydroxyurea DRUG

Given PO

Also known as: HU, HYD, Hydrea, Hydroxycarbamide, Hydurea

Treatment (induction therapy and AFHX or AXX)

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Treatment (induction therapy and AFHX or AXX)

radiation therapy RADIATION

Undergo radiation therapy

Also known as: irradiation, radiotherapy, therapy, radiation

Treatment (induction therapy and AFHX or AXX)

hyperfractionated radiation therapy RADIATION

Undergo hyperfractionated radiation therapy

Treatment (induction therapy and AFHX or AXX)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (induction therapy and AFHX or AXX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

Related Publications (1)

• 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.

  PMID: 35945244 DERIVED

MeSH Terms

Conditions

Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck; Tongue Neoplasms

Interventions

Carboplatin; Taxes; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel; Fluorouracil; Hydroxyurea; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Tongue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Urea; Amides; Therapeutics; Physical Phenomena

Study Officials

• Jonas de Souza

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 6, 2013
• Study Start: March 26, 2013
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

US (1)