NCT00758732

Brief Summary

This trial will compare the efficacy of docetaxel/carboplatin versus docetaxel/liposomal doxorubicin in pretreated patients with advanced ovarian carcinoma and treatment free-interval of at least six months

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Timeline
Completed

Started Oct 2005

Typical duration for phase_2 ovarian-cancer

Geographic Reach
1 country

12 active sites

Status
terminated

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

October 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

5.4 years

First QC Date

September 24, 2008

Last Update Submit

September 25, 2015

Conditions

Ovarian Cancer

Keywords

CancerOvarian cancerChemotherapyDocetaxelCarboplatinPegylated doxorubicinPlatinum sensitive

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (3)

  • Toxicity profile

    Toxicity assessment on each cycle

  • Time to tumor progression

    1 year

  • Overall Survival

    1 year

Study Arms (2)

1

EXPERIMENTAL

Docetaxel/carboplatin

Drug: DocetaxelDrug: Carboplatin

2

EXPERIMENTAL

Docetaxel/Caelyx

Drug: DocetaxelDrug: Liposomal doxorubicin

Interventions

DocetaxelDRUG

Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

Also known as: Taxotere
1
CarboplatinDRUG

Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles

1
Liposomal doxorubicinDRUG

Liposomal doxorubicin at the dose of 20 mg/m2 over a 90 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.

Also known as: Caelyx
2

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed ovarian cancer
  • Stage IIIB/IV
  • Failure to prior chemotherapy with paclitaxel /carboplatin regimen and treatment free interval \> 6 months
  • Presence of two-dimensional measurable disease.
  • Life expectancy of more than 3 months.
  • Age ≥ 18 years.
  • Performance status (WHO) 0-2
  • Adequate bone marrow function (Absolute neutrophil count \>1000/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
  • Adequate liver (Bilirubin\<1.5 times upper limit of normal and SGOT/SGPT\<2 times upper limit of normal) and renal function (creatinine\<2mg/dl)
  • Informed consent

You may not qualify if:

  • Pregnant or nursing
  • Psychiatric illness or social situation that would preclude study compliance'
  • Other concurrent uncontrolled illness
  • Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
  • Other concurrent investigational agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athnes, Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

Department of Medical Oncology, "Marika Iliadis" Hospital of Athens

Athens, Greece

Location

Department of Medical Oncology, Air Forces Military Hospital of Athens

Athens, Greece

Location

Medical Oncology Unit, 401 Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

First Department of Medical Oncology, "Metaxa's" Anticancer Hospital of Pireas

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

Thessaloniki, Greece

Location

Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Interventions

DocetaxelCarboplatinliposomal doxorubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Christos Emmanouilides, MD

    Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2008

First Posted

September 25, 2008

Study Start

October 1, 2005

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

GR(12)