Clinical trial · Interventional
Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
A Multicenter Randomized Phase II Study of Docetaxel/Carboplatin Versus Docetaxel/Pegylated Liposomal Doxorubicin as Second Line Treatment in Patients With Platinum Sensitive Disease
NCT00758732CI-TRIAL-00019221terminatedPhase 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): Poor accrual
Summary
Brief summary (as posted)
This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Docetaxel/carboplatin
- interventionNames
- Drug: Docetaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- 2
- description
- Docetaxel/Caelyx
- interventionNames
- Drug: Docetaxel
- Drug: Liposomal doxorubicin
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed ovarian cancer * Stage IIIB/IV * Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval \> 6 months * Presence of two-dimensional measurable disease. * Life expectancy of more than 3 months. * Age ≥ 18 years. * Performance status (WHO) 0-2 * Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3) * Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl) * Informed consent Exclusion Criteria: * Pregnant or nursing * Psychiatric illness or social situation that would preclude study compliance' * Other concurrent uncontrolled illness * Other invasive malignancy within the past 5 years except nonmelanoma skin cancer * Other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.