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

Uterine Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00782041
• Other study ID #: L_8311
• Status: Terminated
• Phase: Phase 2
• First received: October 28, 2008
• Last updated: September 14, 2009
• Start date: January 2003

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Drug:
• Oxaliplatin
85 mg/m²
• 5-FluoroUracil
2,000 mg/m²
• Folinic acid
20 mg/m²

Locations

Country	Name	City	State
Thailand	Sanofi aventis administrative office	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Throughout the study period	No
Secondary	Progression-free survival		Throughout the study period	No
Secondary	Overall survival		Throughout the study period	No
Secondary	Adverse events		Throughout the study period	No