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A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)


OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of
gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma
of the head and neck. II. Determine the toxicity profile of this combination treatment in
these patients. III. Assess the response rate of treatment in these patients.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine as an
IV bolus on day 1 every 2 weeks. Cisplatin is administered on day 1 every 2 weeks. In the
absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts
of 3 patients each receive escalating doses of gemcitabine on the same schedule. If 1 of 3
patients in each cohort experiences DLT, an additional 3 patients are enrolled at that same
dose level. If 2 of 3 patients experiences DLT in the cohort, then dose escalation ceases
and the next lower dose is declared the maximum tolerated dose. Patients are assessed for
response every 2 weeks. Patients may continue treatment for up to 9 months or until disease
progression.

PROJECTED ACCRUAL: At least 3 patients will be accrued for phase I and 20-40 patients will
be accrued for phase II of this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage III or IV squamous cell carcinoma of
the head and neck that is surgically unresectable and not curable by radiation therapy
Upper aerodigestive tract only Unresectable or recurrent disease following initial therapy
with surgery and/or radiation Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times
institutional normal Transaminases no greater than 3 times institutional normal Renal:
Creatinine clearance greater than 40 mL/min Cardiovascular: Adequate cardiac function No
heart failure Pulmonary: Adequate pulmonary function not requiring supplemental oxygen
Other: Not pregnant Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy allowed Surgery:
Prior surgery allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Raj Sadasivan, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hope Cancer Institute, Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000066004

NCT ID:

NCT00003182

Start Date:

March 1997

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III nasopharyngeal cancer
  • stage IV nasopharyngeal cancer
  • recurrent nasopharyngeal cancer
  • stage III salivary gland cancer
  • stage IV salivary gland cancer
  • recurrent salivary gland cancer
  • salivary gland squamous cell carcinoma
  • 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
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent 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
  • recurrent squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the larynx
  • stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Bethany Medical CenterKansas City, Kansas  66102
Heartland Cancer Research NetworkKansas City, Kansas  66102