Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head a… (NCT00080028) | Clinical Trial Compass
TerminatedPhase 1
Motexafin Gadolinium With Chemotherapy and Radiation Therapy for the Treatment of Advanced Head and Neck Cancer
United States18 participants
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.