Status:
COMPLETED
Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
Lead Sponsor:
ARCAGY/ GINECO GROUP
Collaborating Sponsors:
Schering-Plough
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
Conditions:
Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
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 carbopla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
976 Patients enrolled
Trial Details
Trial ID
NCT00189553
Start Date
April 1 2005
End Date
June 1 2012
Last Update
January 10 2014
Active Locations (1)
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1
Hôpital Hôtel Dieu
Paris, France, 75004