A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Nec… (NCT00148122) | Clinical Trial Compass
CompletedPhase 2
A Study of a New Combination and Schedule of Chemotherapy Drugs for the Treatment of Head and Neck Cancer
United States40 participantsStarted 2002-11
Plain-language summary
The purpose of this study is to determine the effectiveness and side effects of a new combination and schedule of chemotherapy drugs in the treatment of head and neck cancer. Patients with advanced or recurrent head and neck cancer, which is untreatable by surgery or radiation therapy are eligible for this study. Standard treatment for advanced or recurrent head and neck cancer involves the use of chemotherapy.
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:
* Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy.
* Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only).
* Patients must be taxane-naïve (no prior docetaxel or paclitaxel).
* Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible.
* Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration.
* Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy.
* Aged 18 years or older
* Performance status of 0-2 by Zubrod criteria.
* Life expectancy of at least 12 weeks.
* Hematologic: absolute neutrophil count (ANC) equal to or \> 1,500/mm3; hemoglobin equal to or \> 8.0 g/dl; platelets equal to or \> 100,000/mm3.
* Total bilirubin must be within normal institutional limits (WNL).
* Transaminases (AST/SGOT and ALT/SGPT) may be up to 2.5 X the institutional upper limit of normal (ULN) if alkaline phosphatase is less than ULN, or alkaline phosphatase may be up to 4 X ULN if transaminases are less than ULN.
* A calculated creatinine clearance of \> 50 ml/min
* Women of childbearing potential must have a negative pregnancy test at baseline, prior to receiving any study drug. (Pregnant or lactating patients are excluded.)
* Patients of reprod…
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.