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| Name | Class |
|---|---|
| University Hospital of Crete | OTHER |
Topotecan and gemcitabine are drugs globally registered for recurrent ovarian carcinoma. This trial will determine the maximum tolerated dose and the efficacy of this combination administered weekly in patients with platinum -resistant ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hycamptin | Drug | 1.75mg/m2 IV on day 1 every week for 3 weeks in cycles of 4 weeks Number of cycles: until progression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose and the response rate of gemcitabine plus topotecan. | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity profile | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia Kalikaki, MD | University Hospital of Crete, Dep of Medical Oncology | 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 |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| ID | Term |
|---|---|
| D019772 | Topotecan |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
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| Gemcitabine | Drug | Gemcitabine at starting dose of 700 mg/m 2 with increments of 100 mg/m2 IV on day 1 every week for 3 weeks in cycles of four weeks. Number of cycles: until progression |
|
|
| 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 |
| State General Hospital of Larissa, Dep of Medical Oncology | Larissa | Greece |
| "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology | Thessaloniki | Greece |
| 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 |
| D003562 |
| Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |