NCT00189553

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
976

participants targeted

Target at P75+ for phase_3 ovarian-cancer

Timeline
Completed

Started Apr 2005

Typical duration for phase_3 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

3.8 years

First QC Date

September 12, 2005

Last Update Submit

January 9, 2014

Conditions

Ovarian CancerFallopian Tube Cancer

Keywords

Extra-ovarian papillary serous tumorsRelapse over 6 monthsPreviously received taxane derivative

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival of patients in both study groups

    5 years

Secondary Outcomes (3)

  • Qualitative and quantitative toxicities

    6 months

  • Quality of life

    6 months

  • Overall survival

    5 years

Study Arms (2)

Standard

ACTIVE COMPARATOR

Paclitaxel-Carboplatin

Drug: CarboplatinDrug: Paclitaxel

Experimental

EXPERIMENTAL

Caelyx-Carboplatin

Drug: Pegylated liposomal doxorubicinDrug: Carboplatin

Interventions

Pegylated liposomal doxorubicinDRUG

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

Also known as: Caelyx
Experimental
CarboplatinDRUG

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

Also known as: generic drug
ExperimentalStandard
PaclitaxelDRUG

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

Also known as: generic drug
Standard

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Hôtel Dieu

Paris, 75004, France

Location

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

liposomal doxorubicinCarboplatinDrugs, GenericPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPharmaceutical PreparationsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Eric Pujade-Lauraine, MD, PhD

    GINECO GROUP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

April 1, 2005

Primary Completion

January 1, 2009

Study Completion

June 1, 2012

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

FR(1)