Clinical trial · Interventional
Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)
NCT00189553CI-TRIAL-00013373CALYPSOcompletedPhase 3ClinicalTrials.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)
This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (\> 6 months).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pegylated liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard
- description
- Paclitaxel-Carboplatin
- interventionNames
- Drug: Carboplatin
- Drug: Paclitaxel
- type
- EXPERIMENTAL
- label
- Experimental
- description
- Caelyx-Carboplatin
- interventionNames
- Drug: Pegylated liposomal doxorubicin
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Progression-free survival of patients in both study groups
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \> 18 * Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors * Measurable disease (Response Evaluation Criteria in Solid Tumor \[RECIST\] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup \[GCIG\] criteria) or with histologically proven diagnosis of relapse * Disease in progression \> 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative. * ECOG performance status \< 2 * Life expectancy of at least 12 weeks * Adequate bone marrow, renal, and hepatic function Exclusion Criteria: * Ovarian tumors of low malignant potential * Non-epithelial ovarian or mixed epithelial/non-epithelial tumors * Previous radiotherapy * Prior diagnosis of malignancy * Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases * Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade \> 1 * History of congestive heart failure (New York Heart Association \[NYHA\] classification \> 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias * Severe active infection * Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx * Fertile women not using adequate contraceptive methods * Pregnant or breast feeding women
References
Publications (0)
Data not yet available
No reference posted for this study.