Phase II Study of Oxaliplatin and Capecitabine in Advanced Head and Neck Malignancies
Overview
- Phase
- Phase 2
- Intervention
- Oxaliplatin, Capecitabine
- Conditions
- Head or Neck Cancer
- Sponsor
- University of Louisville
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Overall Response Rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This phase II study will test the response rate of combined oxaliplatin and capecitabine treatment when administered at a given dose and schedule, in patients with Head and Neck cancer for which there is no curative treatment.
Detailed Description
The optimal dose and schedule for the combined treatment with oxaliplatin and capecitabine have not been defined. The aim of this Phase II study is to determine the response rate of combined oxaliplatin and capecitabine treatment at a given dose and schedule in patients with Head and Neck cancer for which there is no curative treatment. The study also aims to determine the qualitative and quantitative toxicity and reversibility of toxicity of the above combination and to evaluate any changes in performance status, quality of life, overall survival and progression-free survival.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have histologically or cytologically confirmed squamous cell cancer of Head and Neck
- •Patients must have metastatic or locally recurrent disease
- •Patients must have disease not curable by surgery as estimated by one of the protocol investigators, and should not be eligible for reradiation protocol or have failed reradiation protocol.
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan
- •Age \>18 years of age
- •Life expectancy of greater than 12 weeks
- •ECOG performance status 0, 1 or 2 (Karnofsky \>50%; see Appendix B)
- •Patients must have adequate bone marrow function as defined below:
- •absolute neutrophil count \> 1,500
- •platelets \> 100,000
Exclusion Criteria
- •Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or oxaliplatin
- •Patients who have had chemotherapy or radiotherapy within 4 weeks prior to first treatment in this study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Patients receiving any other investigational agent(s)
- •Patients with symptomatic brain metastases or actively receiving any therapy for brain metastasis (because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events)
- •Active second malignancy in the last 5 years except for non-melanoma skin cancer or carcinoma-in-situ
- •Clinically significant cardiac disease (e.g. congestive heart failure, New York Heart Association Class II or greater, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
- •If patient is unable to swallow, xeloda may be crushed per hospital policy/procedure. See attached Appendix G.
- •Patients who have had an organ allograft.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Pregnancy
Arms & Interventions
Treatment with Study Drugs
Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.
Intervention: Oxaliplatin, Capecitabine
Outcomes
Primary Outcomes
Overall Response Rate
Time Frame: Every two 28 day treatment cycles until subject no longer on treatment due to disease progression
Among the 15 patients treated, 2 (13%) achieved partial response (PR), and 5 (33%) achieved stable disease (SD), for a Overall Response Rate (ORR) of 46% measured by RECIST criteria. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Overall Response Rate (ORR)=PR+CR.
Secondary Outcomes
- Qualitative and Quantitative Toxicity(At study enrollment, Every two 28 day treatment cycles, and at end of treatment due to disease progression)