Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03188159
Status:
UNKNOWN
Last Update Posted:
2018-03-29
First Post:
2017-03-16
Brief Title:
Vinorelbine in Relapsed Platinum Resistant or Refractory C5 High Grade Serous Endometrioid or Undifferentiated Primary Peritoneum Fallopian Tube or Ovarian Cancer
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Phase II Study of Intravenous Vinorelbine in Patients With Relapsed Platinum Resistant or Refractory C5 High Grade Serous Endometrioid or Undifferentiated Primary Peritoneum Fallopian Tube or Ovarian Cancer VIP
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase II study in patients with recurrent platinum resistant or refractory C5 high-grade serous endometrioid or undifferentiated ovarian primary peritoneal or fallopian tube cancer All patients with high-grade serous endometrioid or undifferentiated primary peritoneum fallopian tube or ovarian cancer will be eligible to be screened for this trial and will be required to sign a pre-screening consent form
Detailed Description:
Background Therapeutic Information In ovarian cancer several single agent phase II trials of vinorelbine in recurrent OC have shown variable response rates of 3 - 30 However previous studies have involved all-comers and no reported trials have selected patients based on confirmed pure HGSOC or a biomarker of relevance Preclinical studies suggest that genes involved in microtubule dynamics are significantly over-expressed in C5 tumours Importantly increased sensitivity was demonstrated of C5-like cell lines to tubulin depolymerising agents like vincristine and vinorelbine compared with microtubule stabilizing agents like paclitaxel Subsequent studies on patient derived xenograft PDX models of C5 HGSOC including platinum resistant models showed responses for more than 50 days when treated with vinorelbine providing preclinical proof that vinorelbine may be an effective therapeutic option in targeting the C5 subclass of HGSOC including in platinum resistant or refractory disease
Risk Benefit of Intervention Vinorelbine is a hemisynthetic vinca alkaloid that is traditionally administered intravenously via an infusion The mechanism of action is disruption of microtubules by their reversible binding to tubulin resulting in mitotic spindle dissolution and metaphase arrest in dividing cells This trial will afford patients with C5 relapsed platinum resistant or refractory HGSOC additional treatment options that may potentially have greater benefit than standard chemotherapy
Tolerability The main dose limiting toxicity associated with IV vinorelbine in lung cancer is myelosuppression with Grade 3-4 neutropenia seen in up to 46 of patients However the febrile neutropenia rate was low at 5 Mild to moderate gastrointestinal toxicity was observed with nausea and vomiting being the most common adverse effect Grade 34 nausea or vomiting occurred in 7 - 17 of patients and primary prophylaxis is recommended Neurotoxicity was also reported with the use of vinorelbine Peripheral neuropathy was observed in up to 11 of patientsand neuroconstipation was documented to affect up to 24 of patients however most of these cases were mild grade 1-2 A similar toxicity profile was observed in patients with platinum resistant ovarian cancer treated with vinorelbine Leukopenia was the most common dose limiting toxicity followed by anemia fatigue and nausea
Aim and Objectives of the trial The purpose of this trial is to determine if targeting platinum resistant or refractory C5 high-grade serous high grade endometrioid or undifferentiated ovarian primary peritoneal and fallopian tube with vinorelbine can improve patient outcomes
Risk Benefit of Intervention Vinorelbine is a hemisynthetic vinca alkaloid that is traditionally administered intravenously via an infusion The mechanism of action is disruption of microtubules by their reversible binding to tubulin resulting in mitotic spindle dissolution and metaphase arrest in dividing cells This trial will afford patients with C5 relapsed platinum resistant or refractory HGSOC additional treatment options that may potentially have greater benefit than standard chemotherapy
Tolerability The main dose limiting toxicity associated with IV vinorelbine in lung cancer is myelosuppression with Grade 3-4 neutropenia seen in up to 46 of patients However the febrile neutropenia rate was low at 5 Mild to moderate gastrointestinal toxicity was observed with nausea and vomiting being the most common adverse effect Grade 34 nausea or vomiting occurred in 7 - 17 of patients and primary prophylaxis is recommended Neurotoxicity was also reported with the use of vinorelbine Peripheral neuropathy was observed in up to 11 of patientsand neuroconstipation was documented to affect up to 24 of patients however most of these cases were mild grade 1-2 A similar toxicity profile was observed in patients with platinum resistant ovarian cancer treated with vinorelbine Leukopenia was the most common dose limiting toxicity followed by anemia fatigue and nausea
Aim and Objectives of the trial The purpose of this trial is to determine if targeting platinum resistant or refractory C5 high-grade serous high grade endometrioid or undifferentiated ovarian primary peritoneal and fallopian tube with vinorelbine can improve patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None