Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)
- 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
- 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
- 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
- Pregnancy or not exercising appropriate birth control during the course of the study.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.