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

Ovarian Cancer Clinical Trial

— CALYPSO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189553
• Other study ID #: CALYPSO
• Secondary ID: EudraCT 2004-044
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: January 9, 2014
• Start date: April 2005
• Est. completion date: June 2012

Study information

• Verified date: January 2014
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Ministry for Health and WomenBelgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health CanadaDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNew Zealand: Health Research CouncilNorway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 976
• Est. completion date: June 2012
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Pegylated liposomal doxorubicin
30 mg/m² every 4 weeks during 6 cycles or until progression
• Carboplatin
AUC 5 every 3/4 weeks during 6 cycles or until progression
• Paclitaxel
175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression

Locations

Country	Name	City	State
France	Hôpital Hôtel Dieu	Paris

Sponsors (8)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	AGO Study Group, ANZGOG, Arbeitsgemeinschaft Gynaekologische Onkologie Austria, Canadian Cancer Trials Group, European Organisation for Research and Treatment of Cancer - EORTC, NSGO, Schering-Plough

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival of patients in both study groups		5 years	No
Secondary	Qualitative and quantitative toxicities		6 months	No
Secondary	Quality of life		6 months	No
Secondary	Overall survival		5 years	No