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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
ANZGOG
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
NSGO
Information provided by (Responsible Party):
ARCAGY/ GINECO GROUP

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).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Drug: Pegylated liposomal doxorubicin Drug: Carboplatin Drug: Paclitaxel Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 976 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : April 2005
Actual Primary Completion Date : January 2009
Actual Study Completion Date : June 2012


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Progression-free survival of patients in both study groups [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Qualitative and quantitative toxicities [ Time Frame: 6 months ]
  2. Quality of life [ Time Frame: 6 months ]
  3. Overall survival [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier: NCT00189553     History of Changes
Other Study ID Numbers: CALYPSO
EudraCT 2004-04456-39
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Recurrence
Fallopian Tube Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Disease Attributes
Pathologic Processes
Fallopian Tube Diseases
Neoplasms by Histologic Type
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Carboplatin
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic