Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (CALYPSO)

This study has been completed.
Sponsor:
Collaborators:
Schering-Plough
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
AGO Study Group
ANZGOG
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
NSGO
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00189553
First received: September 12, 2005
Last updated: January 9, 2014
Last verified: January 2014

September 12, 2005
January 9, 2014
April 2005
January 2009   (final data collection date for primary outcome measure)
Progression-free survival of patients in both study groups [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Progression-free survival of patients in both study group
Complete list of historical versions of study NCT00189553 on ClinicalTrials.gov Archive Site
  • Qualitative and quantitative toxicities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival
  • Qualitative and quantitative toxicities
  • Quality of life
Not Provided
Not Provided
 
Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
A Multi-National,Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin and Carboplatin Versus Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (> 6 Months)

This is a study of the efficacy and safety of Caelyx (pegylated liposomal doxorubicin) in combination with carboplatin compared to the standard treatment of paclitaxel and carboplatin in patients with epithelial ovarian cancer in late relapse (> 6 months).

The main purpose of this research study is to find out if treatment of late relapse of ovarian or fallopian tube or primary peritoneal cancer with liposomal doxorubicin (Caelyx) combined with carboplatin will control the tumor growth at least as well as standard treatment of paclitaxel and carboplatin. And it is hoped that substituting paclitaxel with Caelyx in combination with carboplatin will improve the tolerance of the treatment program with at least the same efficacy and fewer side effects.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Drug: Pegylated liposomal doxorubicin
    30 mg/m² every 4 weeks during 6 cycles or until progression
    Other Name: Caelyx
  • Drug: Carboplatin
    AUC 5 every 3/4 weeks during 6 cycles or until progression
    Other Name: generic drug
  • Drug: Paclitaxel
    175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression
    Other Name: generic drug
  • Active Comparator: Standard
    Paclitaxel-Carboplatin
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Experimental
    Caelyx-Carboplatin
    Interventions:
    • Drug: Pegylated liposomal doxorubicin
    • Drug: Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
976
June 2012
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients aged > 18
  • Histologically proven diagnosis of cancer of the ovary, the fallopian tube or extra-ovarian papillary serous tumors
  • Measurable disease (Response Evaluation Criteria in Solid Tumor [RECIST] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup [GCIG] criteria) or with histologically proven diagnosis of relapse
  • Disease in progression > 6 months after a first or second platinum-based line. Patients should have previously received a taxane derivative.
  • ECOG performance status < 2
  • Life expectancy of at least 12 weeks
  • Adequate bone marrow, renal, and hepatic function

Exclusion Criteria:

  • Ovarian tumors of low malignant potential
  • Non-epithelial ovarian or mixed epithelial/non-epithelial tumors
  • Previous radiotherapy
  • Prior diagnosis of malignancy
  • Bowel obstruction, sub-occlusive disease, or presence of symptomatic brain metastases
  • Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 1
  • History of congestive heart failure (New York Heart Association [NYHA] classification > 2), history of myocardial infarction within the last 6 months, or history of atrial or ventricular arrhythmias
  • Severe active infection
  • Severe hypersensitivity to products containing Cremophor EL and/or to compounds chemically related to paclitaxel, carboplatin or Caelyx
  • Fertile women not using adequate contraceptive methods
  • Pregnant or breast feeding women
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00189553
CALYPSO, EudraCT 2004-04456-39
Yes
ARCAGY/ GINECO GROUP
ARCAGY/ GINECO GROUP
  • Schering-Plough
  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
  • AGO Study Group
  • ANZGOG
  • European Organisation for Research and Treatment of Cancer - EORTC
  • NCIC Clinical Trials Group
  • NSGO
Study Chair: Eric Pujade-Lauraine, MD, PhD GINECO GROUP
ARCAGY/ GINECO GROUP
January 2014

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