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Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase II Pilot Study of TPF (Docetaxel, Cisplatin, and 5-FU) Induction Chemotherapy Followed by Concurrent Cisplatin and Reduced Dose Radiation in Locally Advanced Head and Neck Cancer


OBJECTIVES:

Primary

- Determine feeding tube dependency at 12 months in patients with locally advanced head
and neck cancer treated with induction chemotherapy comprising docetaxel, cisplatin,
and fluorouracil followed by cisplatin and reduced-dose radiotherapy.

Secondary

- Determine the progression-free, disease-free, and overall survival of patients treated
with this regimen.

- Determine the pattern of failure in patients treated with this regimen.

- Evaluate the quality of life of patients treated with this regimen.

- Assess pre- and post-treatment swallowing ability of patients and the impact on their
quality of life.

Tertiary

- Quantify salivary flow rates of patients receiving chemotherapy with radiotherapy for
head and neck malignancy.

- Evaluate the quality of saliva by examining total protein concentrations.

- Quantify proangiogenic cytokines (interleukin [IL]-1, IL-6, IL-8, and vascular
endothelial growth factor) in the saliva of these patients.

- Determine the degree of mucositis and xerostomia of patients receiving chemotherapy
with radiotherapy for head and neck malignancy.

- Compare salivary flow rates with the grade of mucositis and xerostomia of patients
receiving chemotherapy with radiotherapy for head and neck malignancy.

OUTLINE: This is a pilot study.

- Induction therapy: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1
hour on day 1 followed by fluorouracil IV continuously on days 1- 4. Patients also
receive filgrastim (G-CSF) subcutaneously (SC) on days 5-14 or pegfilgrastim SC on day
5. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression
or unacceptable toxicity. Patients achieving a partial or clinical complete response
proceed to chemoradiotherapy 3 weeks later.

- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on day 1. Treatment
repeats every 3 weeks for 3 courses in the absence of disease progression or
unacceptable toxicity. Patients also undergo concurrent reduced-dose radiotherapy 5
days a week for 6 weeks.

- Surgery: Approximately 6 to 8 weeks after completing chemoradiotherapy, patients with
residual neck disease or disease initially staged at N2 or greater undergo neck
dissection.

Saliva is collected periodically to measure flow rates and quality; quantify proangiogenic
cytokines (interleukin [IL]-1, IL-6, IL-8 and vascular endothelial growth factor); and
examine the grade of mucositis and xerostomia.

Quality of life is assessed at baseline, before chemoradiotherapy, 1 month after the last
radiation treatment, every 3 months for 1 year, and then every 6 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years and then
annually thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


Inclusion Criteria:



- Histologically confirmed squamous cell carcinoma of the head and neck

- Stage IVA or IVB disease

- Stage III disease allowed provided patient may benefit from organ
preservation or patient refused surgery

- Measurable or evaluable disease

- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min

- Bilirubin normal

- Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:

- 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

Exclusion Criteria:

- Salivary gland, sinus, or nasopharyngeal primary disease

- Evidence of distant metastatic disease

- Pregnant or nursing

- Positive pregnancy test (Fertile patients must use effective contraception during
study treatment and for 3 months after completion of study treatment)

- Other malignancy within the past 5 years except for adequately treated basal cell or
squamous cell skin cancer, in situ cervical cancer, or other malignancy in which
stage and nature of disease is such that it is unlikely to affect survival for the
next 3 years

- Peripheral neuropathy ≥ grade 2

- Hearing loss ≥ grade 2

- Severe hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80 and/or cisplatin or other platinum analogs

- Poor nutritional status, in the opinion of the investigator

- Active infection

- Active ischemic heart disease

- Myocardial infarction within the past 6 months

- Prior radiotherapy above the clavicles

- Prior chemotherapy

- Prior surgery to the primary tumor except biopsy

- Concurrent amifostine or other investigational agents

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Patients With Feeding Tube Dependency

Outcome Description:

All patients were non-evaluable and study was terminated early. There is no measure of outcome.

Outcome Time Frame:

at 12 months

Safety Issue:

No

Principal Investigator

Frank G. Ondrey, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2005LS012

NCT ID:

NCT00352118

Start Date:

March 2006

Completion Date:

April 2008

Related Keywords:

  • Head and Neck Cancer
  • oral complications of radiation therapy
  • oral complications of chemotherapy
  • mucositis
  • xerostomia
  • 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 IV squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • Head and Neck Neoplasms

Name

Location

Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455