NCT00231075

Brief Summary

Safety and Efficacy of Paraplatin in combination with Taxol in patients of 70 years or older with epithelial ovary cancer F.I.G.O. stages III and IV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 ovarian-cancer

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_2 ovarian-cancer

Geographic Reach
1 country

2 active sites

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

January 1, 2001

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

November 3, 2005

Status Verified

September 1, 2005

First QC Date

September 30, 2005

Last Update Submit

November 2, 2005

Conditions

Ovarian Cancer

Keywords

Epithelial ovary cancer F.I.G.O. stages III or IV70 years or older

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the combination Paraplatine + Taxol (at least 6 cures have been administered for a given patient and for the treated population, 50% feasibility)

Secondary Outcomes (5)

  • Toxicity assessment

  • Overall survival

  • Progression-free survival

  • Rate of response

  • Quality of life

Interventions

ParaplatinDRUG
PaclitaxelDRUG

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Histological or cytological proven diagnosis of epithelial ovary cancer F.I.G.O stages III or IV (when only cytological proven diagnosis is available: malignant cells and pelvis tumoral mass and increased CA-125 must be diagnosed simultaneously)
  • Patient aged \> 70 years
  • Neutrophil polynuclears \> 1500/mm3 and Platelets \> 100 000/mm3
  • No clinical icterus
  • Life expectancy of at least 3 months

You may not qualify if:

  • Previous diagnosis of malignancy
  • Previous chemotherapy treatment
  • Previous radiotherapy
  • Hypersensitivity to products containing Cremophore EL
  • Hepatic values: bilirubine \> 2\*LSN, SGOT-SGPT \> 2\*LSN and/or Alkalin phosphatase \> 3\*LSN
  • Myocardiopathy with arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hosptalier Emile Roux

Eaubonne, 95600, France

Location

Centre Hospitalier Lyon-sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

CarboplatinPaclitaxel

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 Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Gilles Freyer, MD, PhD

    Centre Hospitalier Lyon-Sud 69495 Pierre-Bénite cedex

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

January 1, 2001

Study Completion

May 1, 2007

Last Updated

November 3, 2005

Record last verified: 2005-09

Locations

FR(2)