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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Head and Neck Cancer Oropharynx Cancer Larynx Cancer Hypopharynx Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Motexafin Gadolinium Injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Texas, San Antonio Health Science Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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PCYC-0210

Identifier Type: -

Identifier Source: org_study_id