Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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Primary objective: To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma. Secondary objectives: To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.

Official Title
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Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)

Conditions
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Nasopharyngeal Neoplasms

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically or cytologically proven nasopharyngeal carcinoma (NPC) with metastatic or recurrent disease that is not amenable to potentially curative surgery or radiotherapy. They must not have prior chemotherapy for the treatment of metastatic or recurrent disease. Prior neoadjuvant, adjuvant or concurrent chemotherapy is allowed as long as a minimum period of 6 weeks has elapsed since the last day of treatment. This includes the use of carboplatin or cisplatin. Patients must have at least one uni-dimensional measurable lesion (according to RECIST criteria) Prior RT or surgery to the target lesion(s) is allowed as long as there is documented disease progression within the RT/ surgical field, and a minimum period of 6 weeks has elapsed since the last day of treatment. Eastern Cooperative Oncology Group performance status of 0-2 No serious, uncontrolled medical conditions that may be aggravated by treatment. No other malignancy(s), except completely excised basal or squamous cell carcinoma of the skin, or completely treated carcinoma-in-situ of the cervix. Adequate hematological function:absolute granulocyte count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L Adequate renal and hepatic functions:·serum creatinine < 1.25 x upper normal limit (UNL) or a calculated creatinine clearance > 50 mL/min·serum bilirubin < 2 x UNL and Aspartate aminotransferase/Alanine aminotransferase < 3 x UNL Exclusion Criteria: Prior treatment with Oxaliplatin or Gemcitabine. Patients who have persistent grade 2 or more sensory and/or motor neuropathy, or ototoxicity resulting from prior cisplatin/ carboplatin. Active or past history of central nervous system metastasis from the primary tumor Potentially life-threatening infections Patients have used any investigational drug treatment in the month prior to inclusion. Pregnancy or not exercising appropriate birth control during the course of the study. Breast-feeding women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Gemcitabine on Day 1 followed by Oxaliplatin on Day 2. The regimen is given every 2 weeks to a maximum of 12 cycles. | Drug: Gemcitabine<br>* 1000mg/m² over 10mg/m²/min<br>Drug: Oxaliplatin<br>* 100 mg/m² over 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria |  | Baseline to end of study | 
| Safety: Clinical and laboratory criteria |  | Baseline to end of study | 
| The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 |  | Baseline to 30 days post treatment | 
| Occurrence of serious adverse events (SAE) |  | Baseline to 30 days post treatment | 
| Drop-out rate |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms. |  | Baseline to end of study |