Caelyx Biweekly in Heavily Pretreated P… | Clinical Trial

Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caelyx

Drug

40 mg/m² biweekly

Primary outcomes

Occurrence of Palmar-plantar Erythrodysesthesia (PPE)

Time frame: through study completion, an average of 18 months

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

Overall Survival

Time frame: for up to 3 years

Overall survival estimated by the Kaplan-Meier method

Sponsors and collaborators

Lead sponsor

North Eastern German Society of Gynaecological Oncology

Other

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2009
Study completion: 2010
First posted: Sep 15, 2005
Registry last updated: Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed