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.
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Uterine Neoplasms
Female
Uterine Neoplasms
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
Throughout the study period
Safety Issue:
No
Principal Investigator
Paibulsirijit Sompob, MD
Investigator Role:
Study Director
Investigator Affiliation:
Sanofi
Authority:
Thailand: Food and Drug Administration
Study ID:
L_8311
NCT ID:
NCT00782041
Start Date:
January 2003
Completion Date:
Related Keywords:
- Uterine Neoplasms
- Neoplasms
- Uterine Cervical Neoplasms
- Uterine Neoplasms
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