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Keep this study
Lead
ARCAGY/ GINECO GROUP
With
Schering-Plough
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
AGO Study Group
Australia New Zealand Gynaecological Oncology Group
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
NSGO
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
