Clinical trial · Interventional
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
NCT00080028CI-TRIAL-00000719terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Hypopharynx Cancer | Malignant Hypopharyngeal Neoplasm | ALIAS | 0.90 |
| Larynx Cancer | Malignant Laryngeal Neoplasm | CURATED_BROADER | 0.80 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Motexafin Gadolinium Injection | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.