Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
North Eastern Germany Society of Gynaecologic Oncology
ClinicalTrials.gov Identifier:
NCT00170573
First received: September 9, 2005
Last updated: May 13, 2014
Last verified: August 2011

September 9, 2005
May 13, 2014
October 2001
April 2009   (final data collection date for primary outcome measure)
Toxicity [ Time Frame: Toxicity ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00170573 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: Overall survival ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Cancer
Drug: Caelyx
Caelyx 40 mg/ m2biweekly
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
August 2010
April 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00170573
32005000
No
North Eastern Germany Society of Gynaecologic Oncology
North Eastern Germany Society of Gynaecologic Oncology
Not Provided
Principal Investigator: Jalid Sehouli Charité Campus Virchow Klinikum
North Eastern Germany Society of Gynaecologic Oncology
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP