Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse (CALYPSO)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by ARCAGY/ GINECO GROUP.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
ARCAGY/ GINECO GROUP
Collaborators:
Schering-Plough
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
AGO Study Group
ANZGOG
European Organisation for Research and Treatment of Cancer - EORTC
NCIC CTG
NSGO
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00189553
First received: September 12, 2005
Last updated: October 25, 2007
Last verified: October 2007
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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 ]
Secondary Outcome Measures:
- Qualitative and quantitative toxicities [ Time Frame: 6 months ]
- Quality of life [ Time Frame: 6 months ]
- Overall survival [ Time Frame: 5 years ]
| Enrollment: | 976 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | November 2012 |
| 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
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 CTG
NSGO
Investigators
| Study Chair: | Eric Pujade-Lauraine, MD, PhD | GINECO GROUP |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00189553 History of Changes |
| Other Study ID Numbers: | CALYPSO, EudraCT 2004-04456-39 |
| Study First Received: | September 12, 2005 |
| Last Updated: | October 25, 2007 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Austria: Federal Ministry for Health and Women Belgium: Directorate general for the protection of Public health: Medicines 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:
|
Ovarian Neoplasms 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 Fallopian Tube Diseases |
Neoplasms by Histologic Type Doxorubicin Carboplatin Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013