Fallopian Tube Cancer, Ovarian Cancer
Conditions
Keywords
Extra-ovarian papillary serous tumors, Relapse over 6 months, Previously received taxane derivative
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.
Interventions
DRUGPegylated liposomal doxorubicin
30 mg/m² every 4 weeks during 6 cycles or until progression
DRUGCarboplatin
AUC 5 every 3/4 weeks during 6 cycles or until progression
DRUGPaclitaxel
175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression
Sponsors
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
ARCAGY/ GINECO GROUP
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival of patients in both study groups | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative and quantitative toxicities | 6 months |
| Quality of life | 6 months |
| Overall survival | 5 years |
Countries
France
Outcome results
None listed