Ovarian Epithelial Cancer Recurrent
Conditions
Keywords
Phase II study,, Recurrent platinum-sensitive ovarian cancer, docetaxel, Carboplatin, Toxicity
Brief summary
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.
Detailed description
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.
Interventions
DRUGCarboplatin
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
DRUGDocetaxel
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.
Sponsors
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin. * Female * age above 18 years * WHO performance status 0-2 * Life expectancy \> 3 months * Previous treatment with one platinum and taxane containing regimen. * Platinum and taxane sensitive relapse * At least one evaluable/measurable lesion. * Adequate hematologic, renal and liver function * Consent form signed and dated before inclusion
Exclusion criteria
* Prior treatment with more than one line of chemotherapy * Concurrent severe and/or uncontrolled co-morbid medical condition. * History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock * Pregnant or lactating women (or potentially fertile women not using adequate contraception) * Peripheral neuropathy \> Grade 2 * History of allergy to drugs containing the excipient TWEEN 80®. * Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy * Clinical evidence of brain metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | Up to 30 days after last chemotherapy course | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Up to 30 dayes after last chemotherapy course | Response rate according to Resist 1.0 Response rate is the proportion of patients that achieve CR or PR. |
| Progression free survival | Up to 3 year | Time from start of treatment to the earlier date of assessment of progression or death by any cause. |
Countries
Denmark, Finland, Norway
Outcome results
None listed