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Trial to Determine the CR Rate at the Primary Tumor Site After 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head & Neck Carcinoma Treated With Definitive Concurrent Cisplatin & Radiation Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Trial to Determine the CR Rate at the Primary Tumor Site After 2 Cycles of Induction Chemo With Abraxane, Cetuximab, Cisplatin, & 5-FU for Advanced Head & Neck Carcinoma Treated With Definitive Concurrent Cisplatin & Radiation Therapy


Primary objective:

To determine the clinical CR rate (CR-p) at the primary tumor site to an IC regimen of
weekly Abraxane and cetuximab with CF (ACCF) given for two cycles (over 6 weeks) in patients
with locally advanced non-metastatic HNSCC. The assessment of primary tumor site response
will be performed by the treating physician by careful clinical examination using WHO
criteria. Radiographic studies will also be performed to assess primary tumor site response
but will be used primarily to confirm lack of disease progression that may not be detected
based on clinical examination alone.

The secondary objectives include:

- Document the clinical PR rate (PR-p) at the primary tumor site with this IC regimen

- Document the clinical CR and PR rates at the involved regional nodes (CR-n and PR-n)
with this IC regimen

- Document the clinical overall CR rate (CR-o) (defined as achievement of a CR at the
primary tumor site and at the involved regional nodes) and the clinical overall PR rate
(PR-o) with this IC regimen

- Document the CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates by FDG
uptake on PET scan after this IC regimen

- Document radiographic CR (CR-p, CR-n, and CR-o) and PR (PR-p, PR-n, and PR-o) rates as
assessed by conventional CT scan using RECIST criteria after this IC regimen.

- Correlate primary tumor site, nodal and overall tumor response rates based on WHO
criteria of assessment with that based on CT scan and FDG-PET/CT.

- Document and quantify SPARC expression by IHC in primary tumor tissue obtained at
baseline in each patient and attempt to correlate these results with primary tumor site
response to ACCF.

- Document and grade AE's with this IC regimen with a pre-planned safety analysis after
the first ten patients have completed the IC regimen.

- Determine the overall survival (OS), disease-free survival (DFS), and progression-free
survival (PFS) of this patient population.

Inclusion Criteria


Inclusion

- Selected Stages 3 and 4a/b HNSCC: All patients must have T2-T4 primary tumors.
Patients with T1 tumors will be excluded. Although most of these patients will have
regional nodal disease, patients with no nodal disease will also be eligible.

- Oropharynx, hypopharynx, larynx, and oral cavity sub-sites only. Patients with
nasopharyngeal, sinus and other sub-sites of the head and neck, or unknown primary
SCC of the head and neck will NOT be eligible.

- Age ≥18 years

- Signed informed consent.

- ECOG Performance Status (PS) of 0-2 (Appendix 1).

- Adequate vital organ function (serum creatinine < 1.8 mg/dl, total bilirubin mg/dl, ALT and AST hematopoietic function (ANC >/= 1500/ul, Platelets > 100,000/ul, HGB > 9.0 g/dl).

- Patients with reproductive potential must use an effective method of contraception to
avoid pregnancy for the duration of the trial and for three months after completing
treatment.

- If female of childbearing potential, the patient must have a negative pregnancy test.

Exclusion Criteria:

- Peripheral neuropathy > Grade 1.

- Prior chemotherapy, EGFR targeted therapy or radiation therapy for HNSCC.

- History of prior invasive malignancy diagnosed within the last three years other than
local stage non-melanoma skin cancer.

- Be taking cimetidine or allopurinol. Patients must discontinue taking the medication
for one week before receiving treatment with Abraxane.

- Be taking cimetidine or allopurinol. Patients must discontinue taking the medication
for one week before receiving treatment with Abraxane.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the clinical complete response to the primary tumor

Outcome Time Frame:

tumor response

Safety Issue:

No

Principal Investigator

Douglas Adkins, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington Univerisity

Authority:

United States: Food and Drug Administration

Study ID:

08-0911 / 201105504

NCT ID:

NCT00736944

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Washington UniversitySt. Louis, Missouri  63110