A Prospective Observational Study Assessing The Role of IL-6 On The Platelet Protective Effects of Paclitaxel-based Chemotherapy in Patients with Epithelial Ovarian Cancer
- Conditions
- Epithelial Ovarian CancerCancer - Ovarian and primary peritoneal
- Registration Number
- ACTRN12616000923460
- Lead Sponsor
- Icon Cancer Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- Female
- Target Recruitment
- 6
Women with histologically confirmed epithelial ovarian cancer.
Patients considered for neoadjuvant chemotherapy at the participating centres (i.e. planned for carboplatin and paclitaxel first-line neo-adjuvant chemotherapy at the Icon Cancer Care, Johns Hopkins and MD Anderson and Gustave Roussy Gynaecological Oncology clinics)
Age greater than or equal to 18 years
WHO performance status of 0, 1 or 2
Unresolved bowel obstruction
Previous lines of chemotherapy
Radiotherapy within the preceding 3 weeks
Treatment with any investigational agent within the preceding 4 weeks or within 5 half-lives of the investigational agent, whichever is longer.
Known leptomeningeal involvement or intracranial disease
Pregnant or lactating females.
Inability or unwillingness to give informed consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation assessment between IL-6 levels in plasma measured by ELISA and serum platelet levels[Plasma sample collected during screening / baseline, another plasma sample at every day 1 for 3 cycles, potentially another 2 plasma samples at day 8 and 15 for 3 cycles depending upon which chemotherapy regimen is chosen in addition to a final plasma sample at 4 weeks after the last cycle of chemotherapy for a total maximum of 11 blood collections of 10ml for a total of 48 participants. ]
- Secondary Outcome Measures
Name Time Method