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A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel (1 Hour Infusion), Fluorouracil, Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral, Pharynx and Larynx Cancer


Phase 2
15 Years
80 Years
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Study of Induction Chemotherapy Followed by Concomitant Paclitaxel (1 Hour Infusion), Fluorouracil, Hydroxyurea and Hyperfractionated Radiotherapy for Advanced Oral, Pharynx and Larynx Cancer


OBJECTIVES:

- Evaluate the activity of induction chemotherapy with carboplatin and paclitaxel
followed by concurrent fluorouracil, hydroxyurea, paclitaxel, and hyperfractionated
radiotherapy in terms of response rate, pattern of failure, time to progression, and
overall survival in patients with previously untreated advanced oral, pharyngeal, or
laryngeal cancer.

- Assess this treatment regimen in terms of the pattern and degree of clinical acute,
cumulative, and chronic toxic effects in this patient population.

- Assess the rate of organ preservation in resectable patients treated with this regimen.

- Evaluate the quality of life, organ function, and incidence of second primary tumors in
patients treated with this regimen.

- Assess the rate of complications with subcutaneously implanted IV infusion catheters in
patients treated with this regimen.

OUTLINE: Patients receive induction chemotherapy comprising paclitaxel IV over 3 hours
followed by carboplatin IV over 30 minutes weekly for 3 weeks. Treatment repeats every 4
weeks for 2 courses.

At 1-2 weeks after completion of induction chemotherapy, patients receive oral hydroxyurea
every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, radiotherapy twice
daily on days 1-5, and paclitaxel IV over 1 hour on day 2. Treatment repeats every 2 weeks
for 5 courses.

Patients with residual nodal disease or initially staged nodal disease in the absence of
macroscopic residual disease undergo neck dissection after completion of chemoradiotherapy.
Patients with residual disease at the primary site undergo complete excision of disease.
Patients with disease progression or disease recurrence are considered for conventional
surgical management.

Quality of life is assessed every 3 months for 6 months, every 6 months for 1.5 years, and
then annually thereafter.

Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months
thereafter.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 12-18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed squamous cell or poorly differentiated
carcinomas, or lymphoepithelioma of the head and neck

- Stage III carcinoma of the base of the tongue or hypopharynx

- Stage IV carcinoma of the oral cavity, pharynx (including nasopharynx,
oropharynx, and hypopharynx), or larynx

- No distant metastasis

- Measurable disease desirable

- Clinically disease free after prior surgery allowed

PATIENT CHARACTERISTICS:

Age:

- 15 to 80

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN

Renal:

- Creatinine no greater than 2.0 mg/dL

Cardiovascular:

- No clinically significant cardiomyopathy or congestive heart failure

Pulmonary:

- No clinically significant pulmonary dysfunction

Other:

- No severe baseline neurologic deficits

- No uncontrolled active infection other than that not curable without treatment of
cancer

- No sensitivity to Cremophor EL

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- See Disease Characteristics

- Incisional or excisional biopsy and organ sparing procedures (e.g., debulking of
airway compromising tumors or neck dissection) in patients with an existing primary
tumor allowed

- No more than 3 months since prior nonbiopsy procedure

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Athanassios Argiris, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067310

NCT ID:

NCT00004094

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • Head and Neck Neoplasms
  • Mouth Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of Illinois at ChicagoChicago, Illinois  60612
Monroe Medical AssociatesChicago, Illinois  60603