Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer (NCT00448552) | Clinical Trial Compass
CompletedPhase 2
Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer
United States30 participantsStarted 2004-02
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with capecitabine works in treating patients with relapsed or metastatic head and neck cancer.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed head and neck cancer
* Relapsed or metastatic disease
* Measurable disease
* No CNS metastases (unless CNS metastases have been stable for \> 3 months)
* No clinically significant pericardial effusion
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy \> 3 months
* Absolute granulocyte count \> 1,500/mm³
* Platelet count \> 100,000/mm³
* Bilirubin \< 2.0 times upper limit of normal (ULN)
* AST or ALT \< 2.5 times ULN
* Alkaline phosphatase \< 2.5 times ULN (5 times ULN if liver metastases are present or 10 times ULN if bone disease is present)
* Creatinine clearance ≥ 30 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 30 days after completion of study treatment
* No clinically serious, uncontrolled cardiovascular disease
* No New York Heart Association class III-IV heart disease
* No myocardial infarction within the past 6 months
* No congestive heart failure
* No unstable angina
* No arrhythmia
* No concurrent serious, uncontrolled infections
* No other cancer requiring treatment within the past 5 years, except cured nonmelanoma skin cancer or treated in situ cervical cancer
* No loss of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* No history of persistent neurosensory disorder including, but not limited to, peripheral neuropathy
* No history of uncontrolled seizure…
What they're measuring
1
Objective response rate (complete response and partial response)