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

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ClinicalTrials.gov Identifier: NCT00189553
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 10, 2014
Sponsor:
Collaborators:
Schering-Plough
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
AGO Study Group
Australia New Zealand Gynaecological Oncology Group
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
NSGO
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE April 2005
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2007)
Progression-free survival of patients in both study groups [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Progression-free survival of patients in both study groups
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2007)
  • Qualitative and quantitative toxicities [ Time Frame: 6 months ]
  • Quality of life [ Time Frame: 6 months ]
  • Overall survival [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • Overall survival
  • Qualitative and quantitative toxicities
  • Quality of life
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
Official Title  ICMJE 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)
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian Cancer
  • Fallopian Tube Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Standard
    Paclitaxel-Carboplatin
    Interventions:
    • Drug: Carboplatin
    • Drug: Paclitaxel
  • Experimental: Experimental
    Caelyx-Carboplatin
    Interventions:
    • Drug: Pegylated liposomal doxorubicin
    • Drug: Carboplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2007)
976
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
864
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189553
Other Study ID Numbers  ICMJE CALYPSO
EudraCT 2004-04456-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ARCAGY/ GINECO GROUP
Study Sponsor  ICMJE ARCAGY/ GINECO GROUP
Collaborators  ICMJE
  • Schering-Plough
  • Arbeitsgemeinschaft Gynaekologische Onkologie Austria
  • AGO Study Group
  • Australia New Zealand Gynaecological Oncology Group
  • European Organisation for Research and Treatment of Cancer - EORTC
  • NCIC Clinical Trials Group
  • NSGO
Investigators  ICMJE
Study Chair: Eric Pujade-Lauraine, MD, PhD GINECO GROUP
PRS Account ARCAGY/ GINECO GROUP
Verification Date January 2014

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