Clinical trial · Interventional
Patients Who Have Failed First Line Treatment for Locally Advanced and/or Metastatic Cervical Cancer
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.
NCT00782041CI-TRIAL-00002621terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): protocol violation
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FluoroUracil | Drug | Fluorouracil | ALIAS |
| Folinic acid | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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.
- interventionNames
- Drug: Oxaliplatin
- Drug: 5-FluoroUracil
- Drug: Folinic acid
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Throughout the study period
Secondary outcomes (3)
- measure
- Progression-free survival
- timeFrame
- Throughout the study period
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.