Brief Title
Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
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)
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival of patients in both study groups
Secondary Outcome
Qualitative and quantitative toxicities
Condition
Ovarian Cancer
Intervention
Pegylated liposomal doxorubicin
Study Arms / Comparison Groups
Standard
Description: Paclitaxel-Carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
976
Start Date
April 2005
Completion Date
June 2012
Primary Completion Date
January 2009
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eric Pujade-Lauraine, MD, PhD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00189553
Organization ID
CALYPSO
Secondary IDs
EudraCT 2004-04456-39
Responsible Party
Sponsor
Study Sponsor
ARCAGY/ GINECO GROUP
Collaborators
Schering-Plough
Study Sponsor
Eric Pujade-Lauraine, MD, PhD, Study Chair, GINECO GROUP
Verification Date
January 2014