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

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
Ovarian Cancer, Fallopian Tube Cancer

Intervention / Treatment
-----------------
* Drug: Pegylated liposomal doxorubicin
* Drug: Carboplatin
* Drug: Paclitaxel


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Paclitaxel-Carboplatin | Drug: Carboplatin<br>* AUC 5 every 3/4 weeks during 6 cycles or until progression<br>* Other names: generic drug;Drug: Paclitaxel<br>* 175 mg/m² at day 1 every 3 weeks during 6 cycles or until progression<br>* Other names: generic drug;|
| Experimental: Experimental<br>Caelyx-Carboplatin | Drug: Pegylated liposomal doxorubicin<br>* 30 mg/m² every 4 weeks during 6 cycles or until progression<br>* Other names: Caelyx;Drug: Carboplatin<br>* AUC 5 every 3/4 weeks during 6 cycles or until progression<br>* Other names: generic drug;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival of patients in both study groups |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative and quantitative toxicities |  | 6 months | 
| Quality of life |  | 6 months | 
| Overall survival |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extra-ovarian papillary serous tumors, Relapse over 6 months, Previously received taxane derivative