Status:
TERMINATED
Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
Lead Sponsor:
Sanofi
Conditions:
Uterine Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00782041
Start Date
January 1 2003
Last Update
September 15 2009
Active Locations (1)
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1
Sanofi aventis administrative office
Bangkok, Thailand