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A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma


OBJECTIVES:

Primary

- To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle
formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with
local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)

- To evaluate the disease-free survival of patients treated with this regimen. (Phase II)

Secondary

- To identify dose-limiting toxicities in these patients treated with this regimen.
(Phase I)

- To assess the safety and tolerability of this regimen. (Phases I and II)

- To assess progression-free survival and survival of patients treated with this regimen.
(Phase I)

- To assess overall survival in patients treated with this regimen. (Phase II)

- To assess response rates in patients treated with this regimen. (Phases I and II)

OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel
albumin-stabilized nanoparticle formulation followed by a phase II study.

Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV
over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes,
and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D
conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or
larynx

- Diagnosis based on the primary lesion and/or lymph nodes

- Stage III or IV disease (T2, N2-3, M0 or T3-4, any N, M0)

- No primary tumor of the oral cavity, nasopharynx, sinuses, or salivary glands

- No distant metastasis by chest x-ray, CT scan, or PET/CT scan within the past 6 weeks

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-1

- ANC > 1,500/mm^3

- Platelet count > 100,000/mm^3

- Hemoglobin > 9.0 g/dL (transfusion or other intervention to achieve hemoglobin > 8.0
g/dL allowed)

- Bilirubin ≤ 1.5 mg/dL

- AST, ALT, and AP ≤ 2.5 times upper limit of normal

- Serum creatinine ≤ 1.5 mg/dL

- Creatinine clearance ≥ 50 mL/min

- None of the following electrolyte abnormalities grade 3-4 by CTCAE v 3.0:

- Calcium < 7 mg/dL or > 12.5 mg/dL

- Glucose < 40 mg/dL or > 250 mg/dL

- Magnesium < 0.9 mg/dL or > 3 mg/dL

- Potassium < 3 mmol/L or > 6 mmol/L

- Sodium < 130 mmol/L or > 155 mmol/L

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior invasive malignancy, except for nonmelanomatous skin cancer, unless
disease-free for ≥ 3 years

- No prior allergic reaction to study drugs

- No active cardiac disease, defined as any of the following:

- Unstable angina

- Uncontrolled hypertension

- Myocardial infarction within the past 6 months (unless successfully treated with
coronary artery bypass graft or percutaneous transluminal coronary angioplasty)

- Uncontrolled arrhythmia

- Congestive heart failure

- Three or more heart-related hospitalizations within the past year

- No severe chronic obstructive pulmonary disease requiring ≥ 3 hospitalizations within
the past year

- No AIDS

- No pre-existing peripheral sensory neuropathy ≥ grade 2

- No concurrent medical illnesses that would impair patient tolerance to therapy or
limit survival

PRIOR CONCURRENT THERAPY:

- No prior systemic chemotherapy for this cancer

- Prior systemic chemotherapy for a different cancer allowed

- No prior radiotherapy to the region of this cancer that would result in overlap of
radiotherapy fields

- No prior initial surgical treatment (excluding diagnostic biopsy of the primary site
or nodal sampling of neck disease)

- At least 48 hours since prior and no concurrent granulocytic growth factors (e.g.,
filgrastim [G-CSF]) during radiotherapy

- No concurrent erythropoietic growth factors (e.g., darbepoetin, erythropoietin)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation

Outcome Description:

Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Hak Choy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000634258

NCT ID:

NCT00851877

Start Date:

March 2009

Completion Date:

December 2018

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage II squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • tongue cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

University of Texas Southwestern Medical Center Dallas, Texas  
Baylor Research Institute Dallas, Texas  75246