Caelyx Plus Carboplatin Versus Paclitaxel Plus Carboplati... | NCT00189553

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

NCT00189553

Sponsor

ARCAGY/ GINECO GROUP

Status

Completed

Last Update Posted

Jan 10, 2014Estimated

Enrollment

976Actual

Phase

Phase 3

Conditions

Ovarian Cancer
Fallopian Tube Cancer

Interventions

Pegylated liposomal doxorubicin
Carboplatin
Paclitaxel

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2004-04456-39

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Jan 2009Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2014

Last Update Posted Date

Jan 10, 2014Estimated

Name	Class
Schering-Plough	INDUSTRY
Arbeitsgemeinschaft Gynaekologische Onkologie Austria	OTHER
AGO Study Group	OTHER
Australia New Zealand Gynaecological Oncology Group

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

976Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard	Active Comparator	Paclitaxel-Carboplatin	Drug: Carboplatin Drug: Paclitaxel
Experimental	Experimental	Caelyx-Carboplatin	Drug: Pegylated liposomal doxorubicin Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegylated liposomal doxorubicin	Drug	30 mg/m² every 4 weeks during 6 cycles or until progression	Experimental

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

Measure	Description	Time Frame
Qualitative and quantitative toxicities		6 months
Quality of life		6 months
Overall survival

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010051	Ovarian Neoplasms
D005185	Fallopian Tube Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

ID	Term
D056831	Coordination Complexes
D009930	Organic Chemicals
D004364	Pharmaceutical Preparations
D043823	Taxoids

ID	Term
C506643	liposomal doxorubicin
D016190	Carboplatin
D016568	Drugs, Generic
D017239	Paclitaxel