Trials / Completed
CompletedNCT00170573
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- North Eastern German Society of Gynaecological Oncology · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life
Detailed description
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Caelyx | 40 mg/m² biweekly |
Timeline
- Start date
- 2001-09-01
- Primary completion
- 2009-04-01
- Completion
- 2010-08-01
- First posted
- 2005-09-15
- Last updated
- 2024-12-16
- Results posted
- 2024-12-16
Source: ClinicalTrials.gov record NCT00170573. Inclusion in this directory is not an endorsement.