None listed
Conditions
Brief summary
Summary People diagnosed with ovarian cancer will receive chemotherapy either prior to (neoadjuvant chemotherapy) or following surgery (adjuvant chemotherapy). Previous research has confirmed the importance of treating people with ovarian cancer with regimes that contain carboplatin. As with all chemotherapies there are side effects associated with carboplatin treatment which include fatigue, nausea, vomiting and altered kidney function. More importantly, carboplatin treatment can have a significant effect on the bone marrow of people being treated, leading to anaemia and immunosuppression. In particular, carboplatin can decrease the number of cells known as platelets which are responsible for blood clotting. Therefore people whose platelet cell count is low as a result of carboplatin treatment are at risk of bleeding and the treatment doses and timing are affected. Currently, there is no adequate explanation for this observation. There have been reports confirming that paclitaxel can increase the blood concentrations of particular proteins associated with inflammation (cytokines) that are also responsible for stimulating platelet production. One such cytokine is called interleukin-6 (IL-6). This study aims to investigate whether the IL-6 protein is responsible for protecting platelets in people receiving paclitaxel. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above, with histologically confirmed epithelial ovarian cancer considered for neoadjuvant chemotherapy. Study details Participants in this study will receive the standard doses of carboplatin and paclitaxel used for first-line chemotherapy in the ICON Cancer Care, Johns Hopkins and MD Anderson and Gustave Roussy Gynaecological Oncology units. Chemotherapy regimens will be given as per local unit guidelines until the point of completing at least 3-4 cycles of treatment or prior study withdrawal. The primary difference between standard of care and this research is the collection of 10 ml blood for plasma samples for pharmacodynamic assessments at pre-treatment with each cycle of chemotherapy.
Interventions
This study is a prospective observational study assessing the role of IL-6 in the platelet-protective effects of paclitaxel-based chemotherapy in patients with epithelial ovarian cancer (EOC). Participants on this study would be receiving the same chemotherapy treatment regimen if they were not participating in this study and the doses and schedule for this study have been chosen based on the standard doses of carboplatin and paclitaxel used for first-line neo-adjuvant chemotherapy. The chemothe
This study is a prospective observational study assessing the role of IL-6 in the platelet-protective effects of paclitaxel-based chemotherapy in patients with epithelial ovarian cancer (EOC). Participants on this study would be receiving the same chemotherapy treatment regimen if they were not participating in this study and the doses and schedule for this study have been chosen based on the standard doses of carboplatin and paclitaxel used for first-line neo-adjuvant chemotherapy. The chemotherapy regimens will be given as per local unit guidelines of Icon Cancer Care, Johns Hopkins and MD Anderson and Gustave Roussy Gynaecological Oncology clinics until the point of completing at least 3-4 cycles of treatment or prior study. Baseline evaluations are to be performed within four weeks prior to the start of treatment, include complete medical history; informed consent; complete physical examination; height; weight; performance status; vital signs; standard laboratory assessments; CA-125 tumour marker; urine hCG; standard of care imaging; ECG and blood sampling. Day 1 evaluations will include physical examination; weight; performance status; vital signs; standard laboratory assessments; assessment of adverse events and pharmacodynamic blood sampling. For patients on weekly treatments, evaluations on day 8 and day 15 will include physical examination; weight; performance status; vital signs; standard laboratory assessments; assessment of adverse events and pharmacodynamic blood sampling. End of study evaluations at 4 weeks after the last cycle of treatment will be consistent with the day 1 schedule listed above. The primary difference between standard of care and this research is the collection of 10 ml blood for plasma samples for pharmacodynamic assessments at pre-treatment with each cycle of chemotherapy. Specifically there will be a sample collected during screening / baseline, another sample at every day 1 for 3 cycles, potentially another 2 samples at day 8 and 15 for 3 cycles depending upon which chemotherapy regimen is chosen in addition to a final sample at 4 weeks after the last cycle of chemotherapy for a total maximum of 11 samples of 10ml for a total of 48 participants.
Sponsors
Icon Cancer Foundation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed