Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-30 @ 3:26 PM
Study NCT ID:
NCT01309633
Status:
COMPLETED
Last Update Posted:
2019-07-22
First Post:
2011-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Induction Therapy for Locally Advanced Nasopharyngeal Carcinoma (NPC)
Sponsor:
National University Hospital, Singapore
Organization:
Study Overview
Official Title:
Phase II Open-label Study Evaluating Two Loading Regimens of Sunitinib or Bevacizumab Alternating With Cisplatin and Gemcitabine as Systemic Therapy for Locally Advanced or Metastatic Nasopharyngeal Carcinoma (NPC)
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
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:
\- Hypothesis
We hypothesise that intermittent dosing of the anti-angiogenic RTKI sunitinib or bevacizumab prior to systemic cisplatin and gemcitabine chemotherapy to transiently "normalise" tumour vasculature in patients with locally advanced or metastatic NPC will allow greater efficiency in drug and oxygen delivery, thus potentiating sensitivity to chemotherapy. We hypothesise that a loading dose of sunitinib for 7 days is required to achieve this sensitization effect prior to the first cycle of chemotherapy, and that this effect can subsequently be maintained by a 7 day course of sunitinib prior to each subsequent cycle of chemotherapy. The other hypothesis tested is that bevacizumab 7 days prior to chemotherapy will achieve normalization of tumor vasculature as well, and may induce changes in the tumor microenvironment that is beneficial for antitumour effect.
We hypothesise that intermittent dosing of the anti-angiogenic RTKI sunitinib or bevacizumab prior to systemic cisplatin and gemcitabine chemotherapy to transiently "normalise" tumour vasculature in patients with locally advanced or metastatic NPC will allow greater efficiency in drug and oxygen delivery, thus potentiating sensitivity to chemotherapy. We hypothesise that a loading dose of sunitinib for 7 days is required to achieve this sensitization effect prior to the first cycle of chemotherapy, and that this effect can subsequently be maintained by a 7 day course of sunitinib prior to each subsequent cycle of chemotherapy. The other hypothesis tested is that bevacizumab 7 days prior to chemotherapy will achieve normalization of tumor vasculature as well, and may induce changes in the tumor microenvironment that is beneficial for antitumour effect.
Detailed Description:
* Primary objectives
1. To determine the pathological CR\* rate of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
2. To determine the safety and tolerability of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
* Secondary objectives
1. To determine the clinical RR (complete and partial response)+ of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
2. To evaluate the pharmacodynamic effects (imaging, circulating and tissue) of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
3. To evaluate the early pharmacodynamic effects (imaging, circulating and tissue) of 2 loading doses of sunitinib (ie., 12.5mg or 25mg) and 2 dose level of bevacizumab (ie. 7.5mg/kg or 2.5mg/kg) given 1 week prior to administration of cisplatin and gemcitabine chemotherapy.
1. To determine the pathological CR\* rate of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
2. To determine the safety and tolerability of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
* Secondary objectives
1. To determine the clinical RR (complete and partial response)+ of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
2. To evaluate the pharmacodynamic effects (imaging, circulating and tissue) of intermittent sunitinib or bevacizumab administered with combination cisplatin and gemcitabine as systemic therapy for locally advanced or metastatic NPC.
3. To evaluate the early pharmacodynamic effects (imaging, circulating and tissue) of 2 loading doses of sunitinib (ie., 12.5mg or 25mg) and 2 dose level of bevacizumab (ie. 7.5mg/kg or 2.5mg/kg) given 1 week prior to administration of cisplatin and gemcitabine chemotherapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: