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Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)


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

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Trial Information

Phase II Study to Evaluate the Efficacy and Toxicity of Multimodality Treatment With Induction Taxotere/Cisplatin?5-FU (TPF) Chemotherapy Followed by Concomitant Cetuximab and Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)


OBJECTIVES:

Primary

- Evaluate the progression-free survival of patients with locally advanced squamous cell
carcinoma of the head and neck treated with induction chemotherapy comprising
docetaxel, cisplatin, and fluorouracil followed by concurrent cetuximab and
radiotherapy.

Secondary

- Assess the objective response rate in patients treated with this regimen.

- Assess the best overall response rate, overall survival, local-regional control, and
distant failure in patients treated with this regimen.

- Assess the acute and long-term toxicity associated with this regimen in these patients.

- Assess quality of life and swallowing in patients treated with this regimen.

- Determine the accuracy of PET/CT scan in evaluating objective response; in detecting
residual disease at primary sites and nodes; in guiding the recommendation for salvage
surgery or for neck dissection; and in early detection of recurrent or metastatic
disease.

OUTLINE: Patients are stratified according to nodal status (N2b-c or N3 vs N0-2a), tumor
characteristics of invasiveness (present vs absent), human papilloma virus (HPV) status
(positive vs negative), and primary tumor site (hypopharynx vs larynx vs oropharynx).

Patients receive induction chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV
over 1 hour on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3
weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Beginning 3-4 weeks after completion of induction chemotherapy, patients receive cetuximab
IV once weekly for 7 weeks. Beginning 1 week after the first dose of cetuximab, patients
undergo concurrent intensity-modulated radiotherapy or conventional 3-dimensional
radiotherapy once or twice daily 5-6 days a week for up to 6 weeks. Patients with persistent
disease undergo salvage resection of the primary tumor and/or neck dissection approximately
3 months after the completion of radiotherapy.

Patients undergo quality of life and swallowing evaluations periodically.

Patients undergo PET/CT scan at baseline, before beginning radiotherapy, at 6-8 weeks after
completion of study treatment, every 6 months for 5 years, and then annually thereafter.

After completion of study treatment, patients are followed at 4 and 8 weeks, every 2 months
for 2 years, every 3 months for 1 year, and then every 6 months thereafter.

Inclusion Criteria


Inclusion:

- Histologically confirmed (from primary lesion and/or lymph nodes) squamous cell
carcinoma (SCC) of the head and neck, including the following subtypes:

- Oropharynx

- Hypopharynx

- Larynx

- Primary site of tumor must not include any of the following:

- Nasopharynx

- Sinuses

- Salivary glands

- Stage III or IV disease that is unresectable (oropharynx, larynx, or hypopharynx) OR
that is resectable with organ-sparing goal (oropharynx or hypopharynx)

- Measurable disease by CT scan or MRI

- No definitive evidence of distant metastasis

- ECOG performance status 0-1

- ANC ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 8 g/dL

- Total bilirubin ≤ normal

- Except in the case where the elevated total bilirubin is not a sign of liver
disease (i.e., Gilbert syndrome), in which case a total bilirubin ≤ 2 times
upper limit of normal (ULN) is allowed provided direct bilirubin is ≤ ULN

- AST, ALT, and alkaline phosphate (AP) meeting the following criteria:

- AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)

- AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- AP ≤ 5 times ULN AND AST or ALT normal

- Creatinine ≤ 1.5 mg/dL

- Negative pregnancy test (for women of childbearing potential)

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- Willing to undergo laryngoscopy with biopsy of residual tumor at primary site (as
part of a comprehensive evaluation of tumor response after completion of the
induction chemotherapy portion of study treatment)

Exclusion:

- History of severe hypersensitivity reaction to docetaxel or to other drugs formulated
with polysorbate 80

- Other invasive malignancy within the past 3 years, except nonmelanoma skin cancer

- Prior allergic reaction to the study drug(s)

- Concurrent uncontrolled illness including, but not limited to, any of the following:

- Ongoing or active infection

- Psychiatric illness/social situation that would limit compliance with study
requirements

- Significant history of uncontrolled cardiac disease, including any of the
following:

- Uncontrolled hypertension

- Unstable angina

- Myocardial infarction within the past 6 months

- Uncontrolled congestive heart failure

- Cardiomyopathy with decreased left ventricular ejection fraction (i.e.,
LVEF < 45%)

- Uncontrolled condition that, in the opinion of the investigator, would interfere in
the safe and timely completion of study procedures

- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or
evidence of interstitial lung disease on screening chest CT scan

- HIV positivity

- Pregnant or nursing

- Prior chemotherapy for the study cancer

- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiotherapy fields

- Prior chemotherapy, biological therapy, or hormone therapy within the last one year

- Prior initial surgical treatment, except diagnostic biopsy of the primary site or
nodal sampling of neck disease

- Prior radical or modified neck dissection

- Prior therapy that specifically and directly targets the EGFR pathway

- Concurrent investigational agents

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Mercedes Porosnicu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000600998

NCT ID:

NCT00721513

Start Date:

September 2008

Completion Date:

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 III squamous cell carcinoma of the larynx
  • stage III verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096