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Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.


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:



- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

Victoria Villaflor

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-1554

NCT ID:

NCT01847326

Start Date:

March 2013

Completion Date:

December 2015

Related Keywords:

  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Laryngeal Diseases
  • Tongue Neoplasms
  • Carcinoma, Verrucous
  • Salivary Gland Neoplasms
  • Hypopharyngeal Neoplasms
  • Laryngeal Neoplasms
  • Paranasal Sinus Neoplasms
  • Oropharyngeal Neoplasms
  • Nasopharyngeal Neoplasms

Name

Location

University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470