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

NCT00782041TerminatedPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Sanofi

Enrollment

11

Start Date

2003-01-01

Completion Date

2003-08-01

Study Type

INTERVENTIONAL

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.

Interventions

Oxaliplatin5-FluoroUracilFolinic acid

Conditions

Uterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Response rate

Time frame: Throughout the study period

Secondary Outcomes

Progression-free survival

Time frame: Throughout the study period

Overall survival

Time frame: Throughout the study period

Adverse events

Time frame: Throughout the study period

Locations

Sanofi aventis administrative office, Bangkok, Thailand

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