NCT00003328

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy followed by porfiromycin is more effective than radiation therapy alone in treating patients with head and neck cancer. PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of radiation therapy followed by porfiromycin in treating patients with stage III or stage IV head and neck cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_3 head-and-neck-cancer

Geographic Reach
1 country

4 active sites

Status
completed

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

Study Start

First participant enrolled

December 1, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 16, 2004

Completed
Last Updated

May 21, 2010

Status Verified

May 1, 2010

First QC Date

November 1, 1999

Last Update Submit

May 20, 2010

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynx

Interventions

porfiromycinDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV squamous cell (epidermoid) carcinoma of head and neck limited to the oral cavity, oropharynx, hypopharynx, or larynx No distant metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 75,000/mm3 No known bleeding disorder Hepatic: Bilirubin no greater than 2 times normal No end stage liver disease PT and PTT no greater than 1.5 times normal Renal: Creatinine less than 2 times normal No end stage renal disease Cardiovascular: No unstable angina Pulmonary: No severe oxygen dependent chronic obstructive pulmonary disease Other: No other malignancy known to be active within the past 5 years except basal or squamous cell skin cancer outside the planned radiation portals or carcinoma in situ of the cervix No other life threatening illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for head and neck cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for head and neck cancer Surgery: No prior surgery (other than biopsy) for head and neck cancer

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

Sponsors & Collaborators

Study Sites (4)

Veterans Affairs Medical Center - Washington, DC

Washington D.C., District of Columbia, 20422, United States

Location

Health Advance Institute

Peoria, Illinois, 61655-1466, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

PorfiromycinRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTherapeutics

Study Officials

  • Peter M. Glassman, MD, PhD

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 16, 2004

Study Start

December 1, 1997

Last Updated

May 21, 2010

Record last verified: 2010-05

Locations

US(4)