Not provided
Not provided
Not provided
Not provided
Not provided
Poor accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Docetaxel/carboplatin |
|
| 2 | Experimental | Docetaxel/Caelyx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel at the dose of 75mg/m2 over a 60 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity profile | Toxicity assessment on each cycle | |
| Time to tumor progression | 1 year | |
| Overall Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christos Emmanouilides, MD | Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Crete | Heraklion | Crete | 71110 | Greece | ||
| University General Hospital of Alexandroupolis, Dep of Medical Oncology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Carboplatin | Drug | Carboplatin 5 AUC over a 90 min intravenous infusion every 3 weeks for a maximum of 6 consecutive cycles |
|
| Docetaxel | Drug | 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 | Drug | 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. |
|
|
| 1 year |
| 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 |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| C506643 | liposomal doxorubicin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided