NCT00750386

Brief Summary

This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 ovarian-cancer

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

12 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, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
2.5 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

May 23, 2011

Status Verified

May 1, 2011

Enrollment Period

3.2 years

First QC Date

September 9, 2008

Last Update Submit

May 20, 2011

Conditions

Ovarian Cancer

Keywords

CancerOvarian cancerDose-dense chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Determine the maximum tolerated dose and the response rate

    Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes (2)

  • Toxicity profile

    Toxicity assessment on each cycle

  • Time to tumor progression

    1 year

Study Arms (1)

1

EXPERIMENTAL

Paclitaxel/Carboplatin

Drug: PaclitaxelDrug: Carboplatin

Interventions

PaclitaxelDRUG

175 mg/m2, I.V, every 2 weeks

1
CarboplatinDRUG

Carboplatin AUC, I.V, 5 every 2 weeks

1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
  • Patients have to be chemotherapy naive
  • Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
  • Age \>18 years.
  • Performance status (WHO) 0-2
  • Life expectancy of at least three months.
  • 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
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

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

PaclitaxelCarboplatin

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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

May 23, 2011

Record last verified: 2011-05

Locations

GR(12)