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

Primary Purpose

Head and Neck Cancer, Oropharynx Cancer, Larynx Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Motexafin Gadolinium Injection
Sponsored by
Pharmacyclics LLC.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Head and Neck Cancer, SCCHN, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer, Soft palate Cancer, Tonsil Cancer, Base of tongue Cancer, Supraglottic Cancer, Glottic Cancer, Pyriform Sinus Cancer, Pharyngeal wall Cancer, Throat cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center
  • University of Texas, San Antonio Health Science Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 22, 2004
Last Updated
May 4, 2007
Sponsor
Pharmacyclics LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT00080028
Brief Title
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
Official Title
Phase I Trial of Motexafin Gadolinium and Chemoradiation in Locally Advanced, Squamous Cell Carcinoma of the Head and Neck
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmacyclics LLC.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oropharynx Cancer, Larynx Cancer, Hypopharynx Cancer
Keywords
Head and Neck Cancer, SCCHN, Oropharynx Cancer, Hypopharynx Cancer, Larynx Cancer, Soft palate Cancer, Tonsil Cancer, Base of tongue Cancer, Supraglottic Cancer, Glottic Cancer, Pyriform Sinus Cancer, Pharyngeal wall Cancer, Throat cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Motexafin Gadolinium Injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University of Texas, San Antonio Health Science Center
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

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

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