Clinical trial · Interventional
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
Comparison of Quality of Life in Patients With Platinum-sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer When Treated With Treatment With Trabectedin/PLD or Standard Platinum-based Therapy
NCT00170573CI-TRIAL-00083775completedPhase 2Results postedClinicalTrials.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)
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caelyx | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Caelyx
- description
- 40 mg/m² biweekly
- interventionNames
- Drug: Caelyx
Primary outcomes (1)
- measure
- Occurrence of Palmar-plantar Erythrodysesthesia (PPE)
- timeFrame
- through study completion, an average of 18 months
- description
- The outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV. Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain
Secondary outcomes (1)
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years of age * recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial. * Eastern Cooperative Oncology Group (ECOG) performance status less than 3. * renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min) * liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal) * bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l). Exclusion Criteria: * patients with more than 4 chemotherapies in medical history * severe cardiac disease
References
Publications (0)
Data not yet available
No reference posted for this study.