Trial Outcomes & Findings for Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer (NCT NCT00826800)

NCT ID: NCT00826800

Last Updated: 2015-04-15

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2015-04-15

Participant Flow

Protocol Open to Accrual: 01/19/2009 Protocol Closed to Accrual: 04/13/2010 Primary Completion Date (if applicable): 12/28/2010 Recruitment Location is the medical clinic

Participant milestones

Measure	Neoadjuvant FOLFOX Plus Bevacizumab FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant FOLFOX Plus Bevacizumab Chemotherapy in Patients With Locally Advanced Colon Cancer

Baseline characteristics by cohort

Measure	Neoadjuvant FOLFOX Plus Bevacizumab n=2 Participants FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Measure	Neoadjuvant FOLFOX Plus Bevacizumab n=2 Participants FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant. Complete Response	1 participants
To Determine the Pathologic Complete Response (Path CR) Rate in Patients With Locally Advanced (Stage II or III) Colon Cancer to FOLFOX-bevacizumab Administered as Neoadjuvant. Partial Response	1 participants

Adverse Events

Neoadjuvant FOLFOX Plus Bevacizumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Neoadjuvant FOLFOX Plus Bevacizumab n=2 participants at risk FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
Investigations Alanine aminotransferase increased	50.0% 1/2 • Number of events 1
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Number of events 2
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 2/2 • Number of events 4
Investigations Alkaline phosphatase increased	50.0% 1/2 • Number of events 2
Metabolism and nutrition disorders Hypercalcemia	50.0% 1/2 • Number of events 1
Metabolism and nutrition disorders Hyperglycemia	100.0% 2/2 • Number of events 13
Blood and lymphatic system disorders Anemia	100.0% 2/2 • Number of events 19
Investigations White blood cell decreased	50.0% 1/2 • Number of events 4
Investigations Platelet count decreased	50.0% 1/2 • Number of events 4
Metabolism and nutrition disorders Hyperkalemia	100.0% 2/2 • Number of events 2

Additional Information

Dr. Leonard Saltz

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4286

Email: saltzl@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place