Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408694
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2006-12-06
Brief Title:
Bevacizumab Cisplatin Radiation Therapy and Fluorouracil in Treating Patients With Stage IIB Stage III Stage IVA or Stage IVB Nasopharyngeal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy 3D-CRT or Intensity-Modulated Radiation Therapy IMRT Bevacizumab BV for Locally or Regionally Advanced Nasopharyngeal Cancer
Status:
COMPLETED
Status Verified Date:
2018-01
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 II trial is studying how well giving bevacizumab together with cisplatin radiation therapy and fluorouracil works in treating patients with stage IIB stage III stage IVA or stage IVB nasopharyngeal cancer Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of nasopharyngeal cancer by blocking blood flow to the tumor Drugs used in chemotherapy such as cisplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving bevacizumab together with chemotherapy and radiation therapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin fluorouracil and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer
SECONDARY OBJECTIVES
I Determine the 1- and 2-year rates of locoregional progression-free in patients treated with this regimen
II Determine the 1- and 2-year rates of distant metastases-free in patients treated with this regimen
III Determine the 1- and 2-year rates of progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
BEVACIZUMAB AND CHEMORADIOTHERAPY Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Beginning in week 1 patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions
ADJUVANT THERAPY Beginning in week 10 patients receive fluorouracil IV continuously over 96 hours on days 1-4 cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
I Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin fluorouracil and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer
SECONDARY OBJECTIVES
I Determine the 1- and 2-year rates of locoregional progression-free in patients treated with this regimen
II Determine the 1- and 2-year rates of distant metastases-free in patients treated with this regimen
III Determine the 1- and 2-year rates of progression-free and overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
BEVACIZUMAB AND CHEMORADIOTHERAPY Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity Beginning in week 1 patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions
ADJUVANT THERAPY Beginning in week 10 patients receive fluorouracil IV continuously over 96 hours on days 1-4 cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2 and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| U10CA021661 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021661 |
| NCI-2009-00736 | REGISTRY | None | None |
| RTOG-0615 | None | None | None |
| CDR0000518526 | None | None | None |
| RTOG 0615 | OTHER | None | None |
| RTOG-0615 | OTHER | None | None |