Trial Outcomes & Findings for VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer (NCT NCT00407654)

Last Updated: 2024-03-04

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions:Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2024-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	VEGF Trap IV Arm I Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Study STARTED	75
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=75 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Age, Continuous	59 years n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=93 Participants
Age, Categorical >=65 years	21 Participants n=93 Participants
Sex: Female, Male Female	29 Participants n=93 Participants
Sex: Female, Male Male	46 Participants n=93 Participants
Region of Enrollment Canada	49 participants n=93 Participants
Region of Enrollment United States	26 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome measures
Measure	Arm I n=75 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)	1 participants

PRIMARY outcome

Timeframe: 4 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier method will be used.Progression-free survival (Bevacizumab- naïve group)

Outcome measures

Outcome measures
Measure	Arm I n=24 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Progression-free Survival (Bevacizumab- naïve Group)	2.0 months Interval 1.7 to 8.6

PRIMARY outcome

Timeframe: 4 months

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions Kaplan-Meier method will be used. Progression-free survival (Bevacizumab-treated group)

Outcome measures

Outcome measures
Measure	Arm I n=51 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Progression-free Survival (Bevacizumab-treated Group)	2.4 months Interval 1.9 to 3.7

SECONDARY outcome

Timeframe: 12 months

Kaplan-Meier method will be used. (Bevacizumab- naïve Group)

Outcome measures

Outcome measures
Measure	Arm I n=24 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Survival (Bevacizumab-naïve Group)	10.4 months Interval 7.6 to 15.5

SECONDARY outcome

Timeframe: 12 months

Kaplan-Meier method will be used (Bevacizumab-naïve Group)

Outcome measures

Outcome measures
Measure	Arm I n=50 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Survival (Prior Bevacizumab Treated Group)	8.5 months Interval 6.2 to 10.6

SECONDARY outcome

Timeframe: 12 months

Population: data were not collected

Kaplan-Meier method will be used.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Population: data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions; Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Stable disease for atleast 16 weeks

Outcome measures

Outcome measures
Measure	Arm I n=24 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Number of Participants With Response (Bevacizumab-naïve Group)	5 participants

SECONDARY outcome

Timeframe: 6 months

Kaplan-Meier method will be used. (Bevacizumab-treated Group)

Outcome measures

Outcome measures
Measure	Arm I n=51 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Survival (Bevacizumab-treated Group)	8.5 months Interval 6.2 to 10.6

SECONDARY outcome

Timeframe: 12 months

Kaplan-Meier method will be used (Bevacizumab-treated Group)

Outcome measures

Outcome measures
Measure	Arm I n=51 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Overall Survival (Bevacizumab-treated Group)	8.5 months Interval 6.2 to 10.6

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome measures
Measure	Arm I n=50 Participants Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given intravenously laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Number of Participants With Response (Bevacizumab-treated Group)	6 participants

Adverse Events

Arm I

Serious events: 19 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm I n=75 participants at risk Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
Investigations Aspartate aminotransferase increased	1.3% 1/75
Gastrointestinal disorders Rectal pain	1.3% 1/75
Gastrointestinal disorders Rectal hemorrhage	1.3% 1/75
Gastrointestinal disorders Constipation	1.3% 1/75
Vascular disorders Hypertension	2.7% 2/75
General disorders Weight loss	1.3% 1/75
General disorders Pain	1.3% 1/75
Vascular disorders Thromboembolic event	1.3% 1/75
Musculoskeletal and connective tissue disorders Bone pain	1.3% 1/75
Respiratory, thoracic and mediastinal disorders Dyspnea	2.7% 2/75
Gastrointestinal disorders Abdominal pain	2.7% 2/75
General disorders DeathNOS	1.3% 1/75
General disorders Non-cardiac chest pain	2.7% 2/75
Cardiac disorders Chest pain - cardiac	1.3% 1/75
Gastrointestinal disorders Dyspepsia	1.3% 1/75
Gastrointestinal disorders Esophageal pain	1.3% 1/75
Nervous system disorders Headache	1.3% 1/75
Gastrointestinal disorders Esophageal varices hemorrhage	1.3% 1/75
Nervous system disorders Extrapyramidal disorder	1.3% 1/75
Gastrointestinal disorders Colonic obstruction	1.3% 1/75
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	2.7% 2/75
Gastrointestinal disorders Small intestinal obstruction	1.3% 1/75
Cardiac disorders Sinus bradycardia	1.3% 1/75
Metabolism and nutrition disorders Dehydration	1.3% 1/75

Other adverse events

Other adverse events
Measure	Arm I n=75 participants at risk Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. ziv-aflibercept: Given orally laboratory biomarker analysis: Correlative studies pharmacological study: Correlative studies
General disorders Fatigue	86.7% 65/75
Vascular disorders Hypertension	64.0% 48/75

Additional Information

Dr. Malcolm Moore

Princess Margaret Cancer Centre

Phone: 416-945-2263

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60