Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer - Full Text View

Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

This study is ongoing, but not recruiting participants.

Sponsored by:	North Eastern Germany Society of Gynaecologic Oncology
Information provided by:	North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:	NCT00170573

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Drug: Caelyx	Phase II

MedlinePlus related topics:

Cancer Ovarian Cancer

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Study Start Date:	October 2001
Estimated Study Completion Date:	August 2010

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170573

Sponsors and Collaborators

North Eastern Germany Society of Gynaecologic Oncology

Investigators


Principal Investigator:	Jalid Sehouli	Charité Campus Virchow Klinikum

More Information

Study ID Numbers:	32005000
First Received:	September 9, 2005
Last Updated:	April 25, 2008
ClinicalTrials.gov Identifier:	NCT00170573
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:

biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions

Study placed in the following topic categories:

Genital Diseases, Female

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Quality of Life

Endocrine System Diseases

Urogenital Neoplasms

Endocrinopathy

Ovarian Diseases

Doxorubicin

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Antibiotics, Antineoplastic

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on November 06, 2008