Uterine Neoplasms
Conditions
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.
Interventions
DRUGOxaliplatin
85 mg/m²
DRUG5-FluoroUracil
2,000 mg/m²
DRUGFolinic acid
20 mg/m²
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | Throughout the study period |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | Throughout the study period |
| Overall survival | Throughout the study period |
| Adverse events | Throughout the study period |
Countries
Thailand
Outcome results
None listed