Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-02-25 @ 9:36 PM
Study NCT ID:
NCT02079220
Status:
WITHDRAWN
Last Update Posted:
2017-07-31
First Post:
2014-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer
Sponsor:
James J Lee
Organization:
Study Overview
Official Title:
A Phase II Study of Ziv-aflibercept in Combination With Capecitabine/Oxaliplatin (XELOX) Chemotherapy in the Front-Line Treatment of Patients With Metastatic Colorectal Cancer
Status:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding for the study was withdrawn, no participants were ever recruited.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label, two-arm, phase II trial to evaluate the anti-tumor activity, safety, and tolerability of ziv-aflibercept in combination with XELOX chemotherapy in the first-line treatment of subjects with mCRC.
Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator's preference.
Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days.
* Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days.
* Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days.
Arm B (every 3 week schedule):
Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days.
* Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days.
* Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.
Two different schedules of ziv-aflibercept in combination with XELOX will be evaluated in this study: every 2 week schedule (Arm A) and the every 3 week schedule (Arm B). The choice between arm A and arm B will depend on the investigator's preference.
Arm A (every 2 week schedule) Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 1,000 mg/m2 orally twice a day on Days 1 - 7 of each cycle, repeating every 14 days.
* Oxaliplatin: will be administered 85 mg/m2 IV on Day 1 of each cycle, repeating every 14 days.
* Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days.
Arm B (every 3 week schedule):
Dosage and dosage regimen for all study periods
* Capecitabine: will be administered 850 mg/m2 orally twice a day on Days 1 - 14 of each cycle, repeating every 21 days.
* Oxaliplatin: will be administered 130 mg/m2 IV on Day 1 of each cycle, repeating every 21 days.
* Ziv-aflibercept: will be administered 6 mg/kg IV on Day 1 of each cycle, repeating every 21 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: