Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112918
Status:
COMPLETED
Last Update Posted:
2013-08-27
First Post:
2005-06-02
Brief Title:
Combination Chemotherapy With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for High Risk Stage II or Stage III Colon Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Three Arm Multinational Phase III Study to Investigate Bevacizumab q3w or q2w in Combination With Either Intermittent Capecitabine Plus Oxaliplatin XELOX q3w or FluorouracilLeucovorin With Oxaliplatin FOLFOX-4 Versus FOLFOX-4 Regimen Alone as Adjuvant Chemotherapy in Colon Carcinoma The AVANT Study
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:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing 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 Bv may also stop the growth of tumor cells by blocking blood flow to the tumor Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer in adjuvant setting
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens with or without bevacizumab to compare how well they work in treating patients who have undergone surgery for high risk stage II or stage III colon cancer
PURPOSE This randomized phase III trial is studying two different combination chemotherapy regimens with or without bevacizumab to compare how well they work in treating patients who have undergone surgery for high risk stage II or stage III colon cancer
Detailed Description:
This was an open-label Phase III multicenter multinational randomized 3-arm study designed to evaluate the efficacy and safety of bevacizumab in combination with either intermittent fluorouracilleucovorin with oxaliplatin FOLFOX4 or capecitabine plus oxaliplatin XELOX versus FOLFOX4 regimen alone as adjuvant chemotherapy in colon carcinoma
The treatment phase consisted of two parts of 24 weeks for a total of 48 weeks The first part weeks 1 to 24 consisted of treatment with either FOLFOX4 FOLFOX4 in combination with bevacizumab or XELOX in combination with bevacizumab The second part weeks 25 to 48 consisted of single-agent bevacizumab for patients randomized to either bevacizumab-containing arm but was only an observation period for patients assigned to the FOLFOX4-alone arm
Patients were to be followed for recurrencenew occurrence of colorectal cancer and survival Patients who experienced a confirmed recurrence occurrence of a new colorectal cancer during therapy or experienced unacceptable toxicity were to be taken off study treatment but remain in study follow-up Patients that came off therapy due to a confirmed recurrenceappearance of new colorectal cancer were to be followed for survival until the end of the study follow-up period The primary analysis was performed 36 months after the last patient has been randomized After the primary analysis patients continue to be followed for survival for at least a further 2 years ie until all patients have been followed-up for at least 5 years following randomization
The treatment phase consisted of two parts of 24 weeks for a total of 48 weeks The first part weeks 1 to 24 consisted of treatment with either FOLFOX4 FOLFOX4 in combination with bevacizumab or XELOX in combination with bevacizumab The second part weeks 25 to 48 consisted of single-agent bevacizumab for patients randomized to either bevacizumab-containing arm but was only an observation period for patients assigned to the FOLFOX4-alone arm
Patients were to be followed for recurrencenew occurrence of colorectal cancer and survival Patients who experienced a confirmed recurrence occurrence of a new colorectal cancer during therapy or experienced unacceptable toxicity were to be taken off study treatment but remain in study follow-up Patients that came off therapy due to a confirmed recurrenceappearance of new colorectal cancer were to be followed for survival until the end of the study follow-up period The primary analysis was performed 36 months after the last patient has been randomized After the primary analysis patients continue to be followed for survival for at least a further 2 years ie until all patients have been followed-up for at least 5 years following randomization
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 |
|---|---|---|---|
| ROCHE-BO17920A | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |
| P30CA016042 | NIH | None | None |
| UCLA-0412086-01 | None | None | None |