Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052559
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2003-01-24
Brief Title:
Bevacizumab Fluorouracil and External-Beam Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of The Antiangiogenic Agent Bevacizumab In Combination With 5-Fluourouracil And External Beam Radiation Therapy In Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
This phase I trial is studying the side effects and best dose of bevacizumab when given together with fluorouracil and external-beam radiation therapy in treating patients with stage II or stage III rectal cancer Monoclonal antibodies such as bevacizumab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or deliver cancer-killing substances to them Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining monoclonal antibody therapy with chemotherapy and radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of a vascular endothelial growth factor VEGF neutralizing antibody bevacizumab when administered concurrently with 5-fluorouracil 5-FU and external beam radiation therapy EBRT in patients with clinical stage T3 or T4 rectal cancer prior to surgery
II To obtain preliminary data of the pathological response rate after preoperative therapy
III To obtain preliminary data regarding progression free survival local control and overall survival
IV To obtain preliminary data of the changes in the angiogenic profile of rectal cancer induced by this therapy
OUTLINE This is a multicenter dose-escalation study of bevacizumab
Patients receive bevacizumab IV over 30-90 minutes on day 1 courses 1-4 Beginning with course 2 patients also receive fluorouracil IV continuously on days 1-14 and undergo external beam radiotherapy on days 1-5 and 8-12 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgery 7 weeks after completion of chemoradiotherapy
Cohorts of 6 patients receive escalating doses of bevacizumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 20 additional patients are treated at the MTD
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 2 years
I To determine the maximum tolerated dose MTD of a vascular endothelial growth factor VEGF neutralizing antibody bevacizumab when administered concurrently with 5-fluorouracil 5-FU and external beam radiation therapy EBRT in patients with clinical stage T3 or T4 rectal cancer prior to surgery
II To obtain preliminary data of the pathological response rate after preoperative therapy
III To obtain preliminary data regarding progression free survival local control and overall survival
IV To obtain preliminary data of the changes in the angiogenic profile of rectal cancer induced by this therapy
OUTLINE This is a multicenter dose-escalation study of bevacizumab
Patients receive bevacizumab IV over 30-90 minutes on day 1 courses 1-4 Beginning with course 2 patients also receive fluorouracil IV continuously on days 1-14 and undergo external beam radiotherapy on days 1-5 and 8-12 Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Patients undergo surgery 7 weeks after completion of chemoradiotherapy
Cohorts of 6 patients receive escalating doses of bevacizumab until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 20 additional patients are treated at the MTD
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 2 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA062490 | NIH | None | httpsreporternihgovquickSearchU01CA062490 |
| 6042-05-7R1 | None | None | None |
| CDR0000258532 | None | None | None |
| U01CA099118 | NIH | None | None |