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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00080028

Enrollment

Registered

2004-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2007-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer, Hypopharynx Cancer, Larynx Cancer, Oropharynx 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

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.

Interventions

DRUGMotexafin Gadolinium Injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026