Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
NCT ID: NCT00782041
Last Updated: 2009-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2003-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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.
Oxaliplatin
85 mg/m²
5-FluoroUracil
2,000 mg/m²
Folinic acid
20 mg/m²
Interventions
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Oxaliplatin
85 mg/m²
5-FluoroUracil
2,000 mg/m²
Folinic acid
20 mg/m²
Eligibility Criteria
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Inclusion Criteria
* 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
* Peripheral neuropathy \> grade2
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Sanofi-aventis
Principal Investigators
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Paibulsirijit Sompob, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi aventis administrative office
Bangkok, , Thailand
Countries
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Other Identifiers
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L_8311
Identifier Type: -
Identifier Source: org_study_id
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