Status:
TERMINATED
Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ...
Detailed Description
The second-line treatment in advanced ovarian cancer has been proved effective in prolonging overall survival and improving quality of life. In patients with platinum-sensitive ovarian cancer (relapse...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00758732
Start Date
October 1 2005
End Date
March 1 2011
Last Update
September 28 2015
Active Locations (12)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athnes, Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece