Overview

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.