Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
61

Inclusion Criteria

Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
Creatinine clearance (CrCl) > 45 mL/min
Platelets >= 1000,000/ul
...
Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
Creatinine clearance (CrCl) > 45 mL/min
Platelets >= 1000,000/ul
Measurable disease prior to induction chemotherapy
Eastern Cooperative Oncology Group performance status of one or less
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Predominance of disease that is amenable to radiotherapy
Total bilirubin =< 1.5 x institutional upper limit of normal
Prior radiation therapy completed >= 4 months, and/or chemotherapy completed >= 1 month before study entry, and patient should have recovered from any adverse effects
Leukocyte >= 3,000/ul
Life expectancy of greater than 12 weeks
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal
Absolute neutrophil count >= 1,500/ul

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
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
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
...
History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
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
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
Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
Previously untreated patients with locoregional-only disease are not eligible
Patients may not be receiving any other investigational agents

Summary

Conditions
  • Recurrent Squamous Cell Carcinoma of the Nasopharynx
  • 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 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
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 re...

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.

Inclusion Criteria

Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
Creatinine clearance (CrCl) > 45 mL/min
Platelets >= 1000,000/ul
...
Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
Creatinine clearance (CrCl) > 45 mL/min
Platelets >= 1000,000/ul
Measurable disease prior to induction chemotherapy
Eastern Cooperative Oncology Group performance status of one or less
Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
Predominance of disease that is amenable to radiotherapy
Total bilirubin =< 1.5 x institutional upper limit of normal
Prior radiation therapy completed >= 4 months, and/or chemotherapy completed >= 1 month before study entry, and patient should have recovered from any adverse effects
Leukocyte >= 3,000/ul
Life expectancy of greater than 12 weeks
Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal
Absolute neutrophil count >= 1,500/ul

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
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
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
...
History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
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
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
Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
Previously untreated patients with locoregional-only disease are not eligible
Patients may not be receiving any other investigational agents

Locations

Chicago, Illinois, 60637-1470
Chicago, Illinois, 60637-1470

Tracking Information

NCT #
NCT01847326
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Jonas de Souza University of Chicago Comprehensive Cancer Center
  • Jonas de Souza University of Chicago Comprehensive Cancer Center