Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer

May 4, 2007 updated by: Pharmacyclics LLC.

Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Texas
      • San Antonio, Texas, United States
        • University of Texas, San Antonio Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
  • 3+ 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmacyclics LLC.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 22, 2004

First Submitted That Met QC Criteria

March 22, 2004

First Posted (Estimate)

March 23, 2004

Study Record Updates

Last Update Posted (Estimate)

May 8, 2007

Last Update Submitted That Met QC Criteria

May 4, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCYC-0210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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