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A Phase I Study of Concomitant Chemoradiotherapy With Gemcitabine, Paclitaxel, and 5-FU for Patients With Advanced and/or Recurrent Cancer of the Head and Neck


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Phase I Study of Concomitant Chemoradiotherapy With Gemcitabine, Paclitaxel, and 5-FU for Patients With Advanced and/or Recurrent Cancer of the Head and Neck


OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)
of gemcitabine when administered with paclitaxel and fluorouracil with concurrent
hyperfractionated radiotherapy in patients with advanced and/or recurrent head and neck
cancer. II. Determine the MTD and DLT of gemcitabine as a single agent with radiotherapy in
these patients. III. Determine the efficacy of concurrent chemoradiotherapy in terms of time
to progression, pattern of failure, and overall survival in patients with measurable
disease. IV. Determine gemcitabine and fluorouracil pharmacokinetics in these patients.

OUTLINE: This is a dose escalation study of gemcitabine, conducted in two phases. Phase A:
Patients receive fluorouracil IV continuously on days 1-5, paclitaxel IV over 1 hour on day
2, and radiotherapy administered twice daily on days 1-5. This regimen is repeated every 2
weeks for 2 courses, then gemcitabine IV over 30 minutes is added on day 2 after paclitaxel.
This regimen is administered every 2 weeks for 3 courses. Patients with responsive disease
may continue chemotherapy (without radiotherapy) for 2 courses beyond maximum response.
Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which 3 of 6 patients experience
dose-limiting toxicity. Phase B: After the MTD of gemcitabine is determined in phase A,
further dose escalation of gemcitabine may be performed with concurrent radiotherapy
(without fluorouracil or paclitaxel). The MTD is determined as in phase A. Patients are
followed monthly for 1 year and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 30-40 patients will be accrued for this study within
approximately 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven head and neck cancer
requiring regional radiotherapy Locoregional, recurrent disease after primary therapy with
surgery, radiation, or both OR Stage IV, no prior therapy, and not amenable to
conventional therapy with curative intent Metastatic disease allowed if predominant site
and associated symptoms require local treatment in the head and neck region

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count greater
than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin no greater than
1.5 mg/dL Transaminases no greater than 2.5 times upper limit of normal Renal: Creatinine
no greater than 2.0 mg/dL Other: Not pregnant or nursing Fertile patients must use
effective contraception No significant infection No other severe medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from any
prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease
Characteristics Recovered from any prior radiotherapy Surgery: See Disease Characteristics
Recovered from any prior surgery

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:

CDR0000067313

NCT ID:

NCT00004097

Start Date:

August 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III nasopharyngeal cancer
  • stage IV nasopharyngeal cancer
  • recurrent nasopharyngeal cancer
  • untreated metastatic squamous neck cancer with occult primary
  • recurrent metastatic squamous neck cancer with occult primary
  • stage III lip and oral cavity cancer
  • stage IV lip and oral cavity cancer
  • recurrent lip and oral cavity cancer
  • stage III hypopharyngeal cancer
  • stage IV hypopharyngeal cancer
  • recurrent hypopharyngeal cancer
  • stage III laryngeal cancer
  • stage IV laryngeal cancer
  • recurrent laryngeal cancer
  • stage III paranasal sinus and nasal cavity cancer
  • stage IV paranasal sinus and nasal cavity cancer
  • recurrent paranasal sinus and nasal cavity cancer
  • stage III oropharyngeal cancer
  • stage IV oropharyngeal cancer
  • recurrent oropharyngeal cancer
  • Head and Neck Neoplasms

Name

Location

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