Status:
COMPLETED
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- patients with more than 4 chemotherapies in medical history
- severe cardiac disease
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00170573
Start Date
September 1 2001
End Date
August 1 2010
Last Update
December 16 2024
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