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NCT00003182 Clinical Trial

Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00003182
Other study ID # CDR0000066004
Secondary ID HCRN-003NCI-V98-
Status Active, not recruiting
Phase Phase 1/Phase 2
First received November 1, 1999
Last updated December 3, 2013
Start date March 1997

Study information
Verified date July 2000
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• cisplatin

• gemcitabine hydrochloride

Locations
Country Name City State
United States Bethany Medical Center Kansas City Kansas
United States Heartland Cancer Research Network Kansas City Kansas

Sponsors (1)
Lead Sponsor Collaborator
Hope Cancer Institute, Inc.

Country where clinical trial is conducted

United States, 

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