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)
18 Years
N/A
Female
Ovarian Cancer, Fallopian Tube Cancer
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival of patients in both study groups
Outcome Time Frame:
5 years
Principal Investigator
Eric Pujade-Lauraine, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
GINECO GROUP
Authority:
Australia: Department of Health and Ageing Therapeutic Goods Administration
Study ID:
CALYPSO
NCT ID:
NCT00189553
Start Date:
April 2005
Completion Date:
November 2012
Related Keywords:
- Ovarian Cancer
- Fallopian Tube Cancer
- Extra-ovarian papillary serous tumors
- Relapse over 6 months
- Previously received taxane derivative
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Neoplasms, Glandular and Epithelial
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