Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer

Phase II Study of Oxaliplatin in Combination With 5-fluorouracil (5-FU) and Folinic Acid (FA) in Patients Who Have Failed First-line Treatment for Locally Advanced or Metastatic Cervical Cancer.

Primary:

• To assess the overall response rate of oxaliplatin in patients with bidimensionally measurable disease at baseline.

Secondary:

• To assess the safety and tolerability of oxaliplatin
• To assess time to progression and overall survival.

Inclusion Criteria:

• Have Locally advanced/metastatic squamous or adenocarcinoma of the cervix
• Prior therapy with cisplatin allowed
• First-line treatment may have been surgery,radiotherapy or chemotherapy either as a single agent or multi-modality therapy
• Must have measurable disease
• Histologically Proven Carcinoma of the cervix
• ECOG PS ≤2
• No other serious concomitant illness
• Fully recovered from any prior therapy
• Lab: ANC >1500 mm³, Platelets > 100000 mm³, Creatinine ≤ 1.5 x Normal value, Bilirubin ≤ 1.5 x Normal value, SGPT (ALT) ≤ 2.5 x Normal value

Exclusion Criteria:

• Known allergy to one of the study drugs
• Peripheral neuropathy > grade2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.