Clinical trial NCT00003182: Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck
Official title: A Phase I/II Study Using Cisplatin and Gemcitabine (Gemzar) for Advanced Head and Neck Cancer (Squamous Cell Carcinoma)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Bethany Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Heartland Cancer Research Network
state: Kansas
Study officials:
affiliation: Hope Cancer Institute, Inc.
name: Raj Sadasivan, MD, PhD
role: STUDY_CHAIR
References: