Clinical trial · Observational
Docetaxel and Carboplatin as First-line Chemotherapy in Early Stage as Well as Advanced or Metastatic Ovarian Cancer
Randomised Study With Docetaxel, Cisplatin and Cyclophosphamide vs Docetaxel and Carboplatin as First Line Chemotherapy With Advanced or Metastatic Ovarian Cancer
NCT00452985CI-TRIAL-00007824OCSTUDcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary objective: To assess response rate. To record the clinical improvement in relation to stage and histopathological grading. Secondary objective: To determine progression free survival. To find out overall survival. To evaluate the safety of the study regimen.
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 |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- * Injection of Docetaxel * 3-hour gap * Injection of carboplatin
- interventionNames
- Drug: Docetaxel
- Drug: Carboplatin
Primary outcomes (4)
- measure
- Measurements of the disease (assessed clinically and/or by CA-125)
- timeFrame
- At baseline and from administration of drug to end of treatment
- measure
- Response rate
- timeFrame
- From start to end of treatment
- measure
- Clinical examination including neurologic examination, vital signs (blood pressure, heart rate, temperature), weight, assessment of any residual toxicity due to previous therapy, assessment of performance status.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Performance status Karnofsky index ≥ 60%. * Early stage as well as advanced/metastatic ovarian cancer proven by abdominal ultrasonography, chest x-ray, Computerized axial tomography scan. * Histologically: epithelial/germ cell * Haematology: absolute neutrophil count: ≥2X10\^9/L; Platelet: ≥150X10\^9/L; Haemoglobin: ≥ 10g/dL * Liver function: total bilirubin: ≤1X UNL (upper normal limit); Aspartate transaminase \& Alanine aminotransferase: ≤2.5 x UNL; Alkaline phosphatase: ≤2.5 UNL * Renal function: Creatinine: ≤130 µmol/L; If creatinine \> 130 µmol/L, the 24 hour creatinine clearance should be \> 60 ml/min. Exclusion Criteria: * Symptomatic peripheral neuropathy \> grade 1 by National Cancer Institute - Common Toxicity Criteria scale * Uncontrolled diabetes mellitus and uncontrolled hypertension * Pregnant, or lactating patients(patients of childbearing potential must be using adequate contraception). * Active infection or other serious underlying medical condition not compatible with program entry eg. congestive heart failure, previous myocardial infarction within 6 months prior to treatment. 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.