Trial Outcomes & Findings for A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma (NCT NCT00881504)

NCT ID: NCT00881504

Last Updated: 2014-10-20

Results Overview

Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2014-10-20

Participant Flow

9 patients were recruited over the course of the study (2009-2011). All were recruited at Georgetown University Medical Center

Participant milestones

Measure	FOLFOX6 and Bevacizumab Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

FOLFOX6 and Bevacizumab Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks

Overall Study Withdrawal by Subject

1

Baseline Characteristics

A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma

Baseline characteristics by cohort

Measure	FOLFOX6 and Bevacizumab n=8 Participants Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks
Age, Continuous	68.1 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: Primary outcome of 4 participants out of 8 was undetermined due to several reasons including patient refusal of further follow up. Of the 4 patients remaining for analysis, progression free survival of 34, 26.3, 7, and 4.7 weeks was seen.

Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.

Outcome measures

Measure

FOLFOX6 and Bevacizumab n=4 Participants Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks

Progression-free Survival

16.7 weeks Interval 4.7 to 34.0

SECONDARY outcome

Timeframe: 8 weeks

The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.

Outcome measures

Measure

FOLFOX6 and Bevacizumab n=8 Participants Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks

Safety and Toxicity

3 participants

Adverse Events

FOLFOX6 and Bevacizumab

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure

FOLFOX6 and Bevacizumab n=8 participants at risk Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks

Gastrointestinal disorders Perforation of colon

12.5% 1/8 • Number of events 1 • 8 weeks

Other adverse events

Measure	FOLFOX6 and Bevacizumab n=8 participants at risk Treatment with modified FOLFOX6 and Bevacizumab Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay \> 4 weeks
General disorders anorexia	50.0% 4/8 • Number of events 4 • 8 weeks
Blood and lymphatic system disorders hypoalbuminemia	37.5% 3/8 • Number of events 3 • 8 weeks
General disorders hypocalcemia	37.5% 3/8 • Number of events 3 • 8 weeks
Gastrointestinal disorders constipation	75.0% 6/8 • Number of events 6 • 8 weeks
Gastrointestinal disorders diarrhea	37.5% 3/8 • Number of events 3 • 8 weeks
General disorders fatigue	87.5% 7/8 • Number of events 7 • 8 weeks
Endocrine disorders hyperglycemia	62.5% 5/8 • Number of events 5 • 8 weeks
General disorders mucositis/stomitis	50.0% 4/8 • Number of events 4 • 8 weeks
Gastrointestinal disorders nausea	50.0% 4/8 • Number of events 4 • 8 weeks
Nervous system disorders sensory neuropathy	75.0% 6/8 • Number of events 6 • 8 weeks
Blood and lymphatic system disorders low platelet count	37.5% 3/8 • Number of events 3 • 8 weeks
Gastrointestinal disorders hyponatremia	50.0% 4/8 • Number of events 4 • 8 weeks
Gastrointestinal disorders vomiting	50.0% 4/8 • Number of events 4 • 8 weeks

Additional Information

Dr. John L Marshall

Georgetown University Medical Center

Phone: 202-444-7064

Email: marshalj@georgetown.edu

Results disclosure agreements

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