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
  Purpose

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).


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Drug: Pegylated liposomal doxorubicin
Drug: Carboplatin
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by ARCAGY/ GINECO GROUP:

Primary Outcome Measures:
  • Progression-free survival of patients in both study groups [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 976
Study Start Date: April 2005
Study Completion Date: June 2012
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard
Paclitaxel-Carboplatin
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
Experimental: Experimental
Caelyx-Carboplatin
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

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189553

Locations
France
Hôpital Hôtel Dieu
Paris, France, 75004
Sponsors and Collaborators
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
Investigators
Study Chair: Eric Pujade-Lauraine, MD, PhD GINECO GROUP
  More Information

Additional Information:
No publications provided

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT00189553     History of Changes
Other Study ID Numbers: CALYPSO, EudraCT 2004-04456-39
Study First Received: September 12, 2005
Last Updated: January 9, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
New Zealand: Health Research Council
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

Keywords provided by ARCAGY/ GINECO GROUP:
Extra-ovarian papillary serous tumors
Relapse over 6 months
Previously received taxane derivative

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014