Status:
COMPLETED
Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma
Lead Sponsor:
Sanofi
Conditions:
Nasopharyngeal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Secondar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00436800
Start Date
March 1 2005
End Date
October 1 2008
Last Update
September 18 2009
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Hong Kong, Hong Kong