Phase 2
Completed N=77
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
Source: ClinicalTrials.gov NCT00170573 ↗Enrolled (actual)
77
Serious AEs
6.3%
Results posted
Dec 2024
Primary outcomePrimary: Occurrence of Palmar-plantar Erythrodysesthesia (PPE) — 18; 9; 3; 0 Participants
Summary
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Palmar-plantar Erythrodysesthesia (PPE) |
18; 9; 3; 0; 34 | — |
| SECONDARY Overall Survival |
18.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00170573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.