Trial Outcomes & Findings for Folfox-B Study for Patients With Colorectal Liver Metastases (NCT NCT00508872)

Results Overview

Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

Over 4 year study period

Results posted on

2012-08-01

Participant Flow

Recruitment Period: 11/16/05 through 08/24/07. All participants recruited at UT MD Anderson Cancer Center.

Study terminated early due to slow accrual. Two patients recruited, both were taken off study (one at surgery and the second prior to adjuvant care).

Participant milestones

Participant milestones
Measure	FOLFOX-B FOLFOX-B: 5-Fluorouracil 400 mg/m\^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m\^2 IV + Oxaliplatin 85 mg/m\^2 IV
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	FOLFOX-B FOLFOX-B: 5-Fluorouracil 400 mg/m\^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m\^2 IV + Oxaliplatin 85 mg/m\^2 IV
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	1

Baseline Characteristics

Folfox-B Study for Patients With Colorectal Liver Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFOX-B n=2 Participants FOLFOX-B: 5-Fluorouracil 400 mg/m\^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m\^2 IV + Oxaliplatin 85 mg/m\^2 IV
Age Continuous	46 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Over 4 year study period

Population: Intended analysis was per protocol. Study terminated early, leading to only two (2) patients recruited, one not eligible for study and second inevaluable.

Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).

Outcome measures

Outcome data not reported

Adverse Events

FOLFOX-B

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FOLFOX-B n=2 participants at risk FOLFOX-B: 5-Fluorouracil 400 mg/m\^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m\^2 IV + Oxaliplatin 85 mg/m\^2 IV
General disorders Fever	50.0% 1/2 • Number of events 1 • 21 Months
Blood and lymphatic system disorders Deep Vein Thrombosis	50.0% 1/2 • Number of events 1 • 21 Months
General disorders Syncope	50.0% 1/2 • Number of events 1 • 21 Months

Additional Information

Eddie Abdalla, MD/Assistant Professor

UT MD Anderson Cancer Center

Phone: 713-792-6940

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place