Text Size

Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170573
First received: September 9, 2005
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Toxicity [ Time Frame: Toxicity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Overall survival ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: October 2001
Study Completion Date: August 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Caelyx
    Caelyx 40 mg/ m2biweekly
  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

No publications provided

Responsible Party: Prof. Sehouli, Charité Campus Virchow-Klinikum Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00170573     History of Changes
Other Study ID Numbers: 32005000
Study First Received: September 9, 2005
Last Updated: August 2, 2011
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
 Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013