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Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

Dose Dense Administration of Paclitaxel and Carboplatin Combination as 1st Line Treatment in Patients With Ovarian Carcinoma

NCT00750386•Hellenic Oncology Research Group

View on ClinicalTrials.gov

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.

Detailed Description

Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (12)

University Hospital of Crete

Heraklion, Crete, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

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

Athens, Greece

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

Athens, Greece

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

Athens, Greece

Department of Medical Oncology, Air Forces Military Hospital of Athens

Athens, Greece

Medical Oncology Unit, 401 Military Hospital of Athens

Athens, Greece

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

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

Piraeus, Greece

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

Thessaloniki, Greece

Key Dates

Start Date

January 1, 2008

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

May 23, 2011

Enrollment

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

Paclitaxel

DRUG

Carboplatin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

Inclusion Criteria

Exclusion Criteria

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