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A Phase I Study of Concomitant Chemoradiotherapy With 776C85, 5-FU and Hydroxyurea for Patients With Poor Prognosis Oral Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase I Study of Concomitant Chemoradiotherapy With 776C85, 5-FU and Hydroxyurea for Patients With Poor Prognosis Oral Cancer


OBJECTIVES: I. Assess the feasibility of the administration of ethynyluracil concurrently
with fluorouracil and radiotherapy in patients with advanced oral cancer. II. Determine the
maximum tolerated dose (MTD) and dose-limiting toxicities of this regimen in this patient
population.

OUTLINE: This is a dose escalation study of fluorouracil and hydroxyurea. Patients receive
oral ethynyluracil every 12 hours on days 1-7 and oral fluorouracil every 12 hours on days
2-6. Radiotherapy to the head and neck is administered twice daily on days 2-6. Treatment
continues for 5-7 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients
receive escalating doses of fluorouracil until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 3 of 6 patients
experience dose limiting toxicities. Once the MTD of fluorouracil is determined, hydroxyurea
is added to the treatment regimen. Patients receive fluorouracil and ethynyluracil as per
the treatment schedule outlined above. Patients also receive oral hydroxyurea every 12 hours
for 11 doses on days 1-6. Radiotherapy is administered as above. Cohorts of 3-6 patients
receive escalating doses of hydroxyurea until the MTD is determined. Once the MTD of
fluorouracil and hydroxyurea are determined, an additional 10 patients receive Phase II
doses of ethynyluracil, fluorouracil and hydroxyurea as per the treatment schedule outlined
above. Treatment continues in the absence of unacceptable toxicity. Patients are followed at
4-6 weeks, then every 6 months until death.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced malignant oral
or laryngeal neoplasm requiring regional radiotherapy and not amenable to standard therapy
Tumor site amenable to radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Expected 2 year survival less than 10% in previously untreated patients Hematopoietic: WBC
at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal:
Creatinine clearance at least 50 mL/min Other: No severe infection or medical illness that
would preclude study Must be able to swallow and retain oral medications Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Recovered from prior
radiotherapy Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Everett E. Vokes, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

NU-V95N4

NCT ID:

NCT00004901

Start Date:

October 1999

Completion Date:

July 2004

Related Keywords:

  • Head and Neck Cancer
  • stage IV hypopharyngeal cancer
  • recurrent hypopharyngeal cancer
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • stage IV adenoid cystic carcinoma of the oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent verrucous carcinoma of the oral cavity
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • Head and Neck Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611