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A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.
Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.
Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carboplatin and docetaxel | Experimental | Intravenous infusion every 3 weeks Carboplatin plus docetaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Carboplatin, AUC5, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Safety will be established by grading the observed toxicities using the NCI Common Toxicity Criteria (CTC Version 2.0). All toxicities observed within 30 dayes of last chemocourse will be included. | Up to 30 days after last chemotherapy course |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR. | Up to 30 dayes after last chemotherapy course |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunnar B Kristensen, MD, PhD | NSGO-CTU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9000 | Denmark | |||
| Herlev University Hospital |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Docetaxel | Drug | 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops. |
|
|
Time from start of treatment to the earlier date of assessment of progression or death by any cause.
| Up to 3 year |
| Copenhagen |
| 2730 |
| Denmark |
| Tampere University Hospital | Tampere | Finland |
| Norwegian Radium Hospital | Oslo | 0310 | Norway |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |