Clinical trial NCT00189553: Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Keywords: Extra-ovarian papillary serous tumors
Relapse over 6 months
Previously received taxane derivative
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Schering-Plough
name: Arbeitsgemeinschaft Gynaekologische Onkologie Austria
name: AGO Study Group
name: Australia New Zealand Gynaecological Oncology Group
name: European Organisation for Research and Treatment of Cancer - EORTC
name: NCIC Clinical Trials Group
name: NSGO
First posted: 2005-09-19
Enrollment: 976
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free survival of patients in both study groups
timeFrame: 5 years
Secondary outcomes:
measure: Qualitative and quantitative toxicities
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hôtel Dieu
Study officials:
affiliation: GINECO GROUP
name: Eric Pujade-Lauraine, MD, PhD
role: STUDY_CHAIR
References: