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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
74
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
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.
Aalborg University Hospital
Aalborg, Denmark
Herlev University Hospital
Copenhagen, Denmark
Tampere University Hospital
Tampere, Finland
Norwegian Radium Hospital
Oslo, Norway
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.
Time frame: Up to 30 days after last chemotherapy course
Response rate
Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR.
Time frame: Up to 30 dayes after last chemotherapy course
Progression free survival
Time from start of treatment to the earlier date of assessment of progression or death by any cause.
Time frame: Up to 3 year
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