Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
NCT ID: NCT00758732
Last Updated: 2015-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
34 participants
INTERVENTIONAL
2005-10-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Docetaxel/carboplatin
Docetaxel
Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Carboplatin
Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
2
Docetaxel/Caelyx
Docetaxel
Docetaxel at the dose of 40mg/m2 over a 60 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.
Liposomal doxorubicin
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.
Interventions
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Docetaxel
Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Carboplatin
Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles
Docetaxel
Docetaxel at the dose of 40mg/m2 over a 60 min intravenous infusion every 2 weeks in 28 days cycle for a maximum of 6 consecutive cycles.
Liposomal doxorubicin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Principal Investigators
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Christos Emmanouilides, MD
Role: PRINCIPAL_INVESTIGATOR
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Locations
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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
Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki
Thessaloniki, , Greece
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
Thessaloniki, , Greece
Countries
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Other Identifiers
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CT/05.09
Identifier Type: -
Identifier Source: org_study_id
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