Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer (NCT00503997) | Clinical Trial Compass
CompletedPhase 2
Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer
United States42 participantsStarted 2006-12
Plain-language summary
RATIONALE: Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pemetrexed together with oxaliplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed together with oxaliplatin works in treating patients with locally 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.
DISEASE CHARACTERISTICS:
Inclusion criteria:
Patients must meet all of the following criteria in order to be eligible for entry into the trial:
* Histologically or cytologically confirmed stage III - IVB HNSCC (includes unknown primary and ParaNasal Sinus cancers)but excludes nasopharyngeal, salivary gland or skin primaries (No TNM staging required)
* Patients must have a measurable disease defined by RECIST criteria
* Age \> 18 years
* ECOG Performance Score of 0, 1 or 2
* Adequate bone marrow as evidenced by:
* Absolute neutrophil count \> 1,500/μL
* Platelet count \> 100,000/μL
* Adequate renal function as evidenced by serum creatinine \< 1.5 mg/dL and CrCl \> 45 mL/min as determined by calculated creatinine clearance using the Cockroft-Gault formula:
* CrCl = (140-age) x (weight in kg)/72 x serum creatinine
* Multiply by 0.85 (85%) for females
* Adequate hepatic function as evidenced by:
* Serum total bilirubin \< 1.5 mg/dL
* Alkaline phosphatase \< 3X the ULN for the reference lab
* SGOT/SGPT \< 3X the ULN for the reference lab
* Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
* Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive, double barrier method or surgical intervention res…
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.
What they're measuring
1
Patient Response to Treatment Measured by RECIST Criteria