Clinical trial · Interventional
Oxaliplatin and Capecitabine in Treating Patients With Relapsed or Metastatic Head and Neck Cancer
Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine
NCT00448552CI-TRIAL-00025179completedPhase 2ClinicalTrials.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)
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.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate (complete response and partial response)
Secondary outcomes (2)
- measure
- Toxicity as measured by NCI CTC
- measure
- Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 seizures or CNS disorders * No history of psychiatric disability or other serious uncontrolled medical condition that would preclude study compliance * No history of clinically significant interstitial lung disease and/or pulmonary fibrosis * No prior hypersensitivity or unanticipated severe reaction to fluoropyrimidine therapy, fluorouracil, or platinum-based compounds PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic or relapsed disease * More than 4 weeks since prior major surgery and recovered * More than 4 weeks since prior participation in any investigational drug study * At least 6 months since prior adjuvant fluoropyrimidine therapy * No other prior fluoropyrimidines * At least 6 months since prior adjuvant platinum-based therapy * No other prior platinum-based therapy * No concurrent radiotherapy to the head and neck * No other concurrent chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.