Clinical trial · Interventional
Efficacy and Safety Study of Oxaliplatin/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
A Phase II Trial Evaluating Efficacy and Safety of Opatin® (Oxaliplatin)/5-FU in Patients With Recurrent or Metastatic Head and Neck Cancer
NCT01370876CI-TRIAL-00012921terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): company policy
Summary
Brief summary (as posted)
To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer and to assess the safety profile of these treatment regimen.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of the Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Neoplasms, Head and Neck | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oxaliplatin/5-FU
- interventionNames
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- every 12 weeks
- description
- To evaluate the objective response rate of oxaliplatin combined with 5-FU in patients with recurrent or metastatic head and neck cancer
Secondary outcomes (1)
- measure
- Safety
- timeFrame
- Each patient will be followed for 30 days after the last dose of study medication
- description
- To assess number of participants with adverse events of these treatment regimen
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have been histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) except nasopharyngeal cancer. * Patients must have recurrent or metastatic disease and for which curative surgery or radiotherapy do not exist or are no longer effective. * Prior to entering the protocol treatment, it has to be more than 6 months interval between previous systemic chemotherapy and protocol treatment. * The disease must have been measurable by computed tomographic (CT) scan or MRI (done within 30 days of study entry) and the diameter of the target tumor is at least more than 1 cm. * Patients must be 20 years of age and 75 years of age. * Patients must have an ECOG performance status score 2. * Patient's hematologic function, liver function and renal function must meet the eligibility requirements. * Patients must sign the informed consent. Exclusion Criteria: * Patients with known hypersensitivity history to Platinum compounds or to 5-Fluorouracil. * Patients with brain metastases. * Patients with bone metastases only. * Patients with pregnancy or breast-feeding. * Patient with CTC (NCI Common Toxicity Criteria) grade 2 peripheral neuropathy of any cause that is clinically detectable. * Patients who have serious concomitant illness that might be aggravated by chemotherapy and other conditions which will be judged by physician's discretion. * Patients who are receiving other anticancer cancer drug(s) for SCCHN.
References
Publications (0)
Data not yet available
No reference posted for this study.