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

Phase 2

Terminated

• Conditions: Uterine Neoplasms
• Interventions: Drug: Oxaliplatin; Drug: 5-FluoroUracil; Drug: Folinic acid

• Registration Number: NCT00782041
• Lead Sponsor: Sanofi

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 assess time to progression and overall survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2003-08
• Study First Submitted: 2008-10-28
• Study First Submitted QC: 2008-10-28
• Study First Posted: 2008-10-29
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Oxaliplatin	Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
1	Folinic acid	Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.
1	5-FluoroUracil	Oxaliplatin 85 mg/m² over 3 hours at Day 1 and Day 15. 5-FU 2,000 mg/m² over 4 hours at Day 1. Folinic acid 20 mg/m² Bolus at Day 1.

Primary Outcome Measures

Name	Time	Method
Response rate	Throughout the study period

Secondary Outcome Measures

Name	Time	Method
Overall survival	Throughout the study period
Progression-free survival	Throughout the study period
Adverse events	Throughout the study period

Trial Locations

Locations (1)

Sanofi aventis administrative office; 🇹🇭 Bangkok, Thailand