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Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

N

North Eastern German Society of Gynaecological Oncology

Status and phase

Completed
Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Caelyx

Study type

Interventional

Funder types

Other

Identifiers

NCT00170573
32005000

Details and patient eligibility

About

Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions 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.

Enrollment

82 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

82 participants in 1 patient group

Caelyx
Experimental group
Treatment:
Drug: Caelyx

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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