Trial Outcomes & Findings for First-Line FOLFOX-Bevacizumab for Advanced Colorectal Cancer With Wild-Type Ras (NCT NCT01057017)

NCT ID: NCT01057017

Last Updated: 2020-02-17

Results Overview

To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: every 3 weeks until patient comes off study (progressive disease), for up to 2 years
• Results posted on: 2020-02-17

Participant Flow

5 Patients were enrolled at The Miriam and Rhode Island Hospital

Participant milestones

Measure	Panitumumab and Bevacizumab Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

First-Line FOLFOX-Bevacizumab for Advanced Colorectal Cancer With Wild-Type Ras

Baseline characteristics by cohort

Measure	Intervention n=5 Participants Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: every 3 weeks until patient comes off study (progressive disease), for up to 2 years

To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3

Outcome measures

Measure	Panitumumab and Bevacizumab n=5 Participants Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab	1 participants

Adverse Events

Intervention

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=5 participants at risk Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression
Investigations Anorexia (3), nausea(3), vomiting(2), weakness(3), confusion(1), hypok(3), hypophos(3), hypoca(3)	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)

Other adverse events

Measure	Intervention n=5 participants at risk Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression. Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression
Investigations Fatigue	40.0% 2/5 • Number of events 2 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations Rash	80.0% 4/5 • Number of events 4 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations Skin Redness	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations Constipation	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations Yeast Infection	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations Alk Phos	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations AST	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations dehydration	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)
Investigations abd pain	20.0% 1/5 • Number of events 1 • from time of signing consent to 30 days post last dose of drug (occurred up to approximately 10 months)

Additional Information

Howard Safran, MD

BrUOG

Phone: 4018633000

Email: Hsafran@lifespan.org

Results disclosure agreements

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