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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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.