Trial | NCT00189553  Report issue

Title

Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    976
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).
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 Started
Apr 30
2005
Primary Completion
Jan 31
2009
Study Completion
Jun 30
2012
Last Update
Jan 10
2014
Estimate

Drug Pegylated liposomal doxorubicin

30 mg/m² every 4 weeks during 6 cycles or until progression

  • Other names: Caelyx

Drug Carboplatin

AUC 5 every 3/4 weeks during 6 cycles or until progression

  • Other names: generic drug

Drug Paclitaxel

175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression

  • Other names: generic drug

Standard Active Comparator

Paclitaxel-Carboplatin

Experimental Experimental

Caelyx-Carboplatin

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
No Results Posted