Docetaxel/Carboplatin Versus Docetaxel/Caelyx in Pretreated Patients With Ovarian Carcinoma
- Conditions
- Ovarian Cancer
- Interventions
- Registration Number
- NCT00758732
- Lead Sponsor
- Hellenic Oncology Research Group
- 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
- 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 (relapsed disease after 6 months from the end of first line chemotherapy) the combination of paclitaxel/carboplatin is considered the standard treatment. Generally, the combination platinum-based chemotherapy may well be associated with a survival benefit in patients with platinum-sensitive disease. Carboplatin, pegylated doxorubicin (caelyx) docetaxel, have been approved for second-line treatment of ovarian carcinoma and seem to be active in platinum-sensitive disease.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Liposomal doxorubicin Docetaxel/Caelyx 1 Carboplatin Docetaxel/carboplatin 1 Docetaxel Docetaxel/carboplatin 2 Docetaxel Docetaxel/Caelyx
- Primary Outcome Measures
Name Time Method Overall Response Rate Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
- Secondary Outcome Measures
Name Time Method Overall Survival 1 year Toxicity profile Toxicity assessment on each cycle Time to tumor progression 1 year
Trial Locations
- Locations (12)
University Hospital of Crete
🇬🇷Heraklion, Crete, 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
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
University General Hospital of Alexandroupolis, Dep of Medical Oncology
🇬🇷Alexandroupolis, Greece
"IASO" General Hospital of Athnes, Dep of Medical Oncology
🇬🇷Athens, Greece
Medical Oncology Unit, 401 Military Hospital of Athens
🇬🇷Athens, Greece
Medical Oncology Unit, "AXEPA" General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece