NCT00003182

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1997

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

August 2, 2004

Completed
Last Updated

December 4, 2013

Status Verified

July 1, 2000

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Head and Neck Cancer

Keywords

stage III nasopharyngeal cancerstage IV nasopharyngeal cancerrecurrent nasopharyngeal cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland cancersalivary gland squamous cell carcinomastage III lip and oral cavity cancerstage IV lip and oral cavity cancerrecurrent lip and oral cavity cancerstage III hypopharyngeal cancerstage IV hypopharyngeal cancerrecurrent hypopharyngeal cancerstage III laryngeal cancerstage IV laryngeal cancerrecurrent laryngeal cancerstage III paranasal sinus and nasal cavity cancerstage IV paranasal sinus and nasal cavity cancerrecurrent paranasal sinus and nasal cavity cancerstage III oropharyngeal cancerstage IV oropharyngeal cancerrecurrent oropharyngeal cancerstage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavity

Interventions

cisplatinDRUG
gemcitabine hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Bethany Medical Center

Kansas City, Kansas, 66102, United States

Location

Heartland Cancer Research Network

Kansas City, Kansas, 66102, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNasopharyngeal NeoplasmsSalivary Gland NeoplasmsMouth NeoplasmsHypopharyngeal NeoplasmsLaryngeal NeoplasmsOropharyngeal NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesMouth DiseasesSalivary Gland DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Raj Sadasivan, MD, PhD

    Hope Cancer Institute, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 2, 2004

Study Start

March 1, 1997

Last Updated

December 4, 2013

Record last verified: 2000-07

Locations

US(2)