NCT00080028

Brief Summary

The purpose of this study is to evaluate the safety of adding the investigational drug Motexafin Gadolinium to the standard treatment of radiation therapy and chemotherapy with drugs called 5-FU and cisplatin in patients with advanced head and neck cancer.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
18

participants targeted

Target at P25-P50 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
Last Updated

May 8, 2007

Status Verified

May 1, 2007

First QC Date

March 22, 2004

Last Update Submit

May 4, 2007

Conditions

Head and Neck CancerOropharynx CancerLarynx CancerHypopharynx Cancer

Keywords

Head and Neck CancerSCCHNOropharynx CancerHypopharynx CancerLarynx CancerSoft palate CancerTonsil CancerBase of tongue CancerSupraglottic CancerGlottic CancerPyriform Sinus CancerPharyngeal wall CancerThroat cancer

Interventions

Motexafin Gadolinium InjectionDRUG

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • Each patient must sign a study-specific informed consent form
  • Newly diagnosed, locally advanced, non-metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) arising from a primary site in the oropharynx, hypopharynx, or larynx confirmed by evaluation of fine needle aspiration or biopsy samples and MRI
  • Eligible for curative intent treatment with hyperfractionated radiation and concurrent 5-FU and cisplatin
  • Karnofsky Performance Status score of at least 60%
  • Primary tumor at least 4 cm in diameter

You may not qualify if:

  • Laboratory Values of:
  • Serum creatinine \> 1.8 mg/dL; unless 24-hour urine creatinine clearance is ≥ 70 mL/min
  • Serum total bilirubin \> 1.5 times the upper limit of normal
  • ALT (formerly SGPT) \> 1.5 times the upper limit of normal
  • Alkaline phosphatase \> 1.5 times the upper limit of normal
  • Absolute neutrophil count (ANC) \< 1500/L
  • Platelet count \< 100,000/L
  • + or greater proteinuria on urinalysis
  • and
  • Squamous Cell Carcinoma of the Head and Neck arising from a primary site in the oral cavity or nasopharynx
  • Distant metastases
  • Prior history of cancer at any site treated with radiotherapy and/or chemotherapy
  • History of SCCHN diagnosed within 5 years of current diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, United States

Location

University of Texas, San Antonio Health Science Center

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsOropharyngeal NeoplasmsLaryngeal NeoplasmsHypopharyngeal NeoplasmsTonsillar Neoplasms

Interventions

motexafin gadolinium

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2004

First Posted

March 23, 2004

Last Updated

May 8, 2007

Record last verified: 2007-05

Locations

US(2)