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VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Phase II Trial of VEGF Trap in Patients With Previously Treated Metastatic Colorectal Cancer

NCT00407654•National Cancer Institute (NCI)

Summary

This phase II trial is studying how well VEGF Trap works in treating patients with previously treated metastatic colorectal cancer. VEGF Trap may stop the growth of colorectal cancer by blocking blood flow to the tumor.

Detailed Description

PRIMARY OBJECTIVES: I. Determine the response rate (complete and partial) in patients with previously treated metastatic colorectal cancer treated with VEGF Trap. II. Determine the incidence of disease stabilization, in terms of 4-month progression-free survival, in patients treated with this drug. SECONDARY OBJECTIVES: I. Determine the median survival time of patients treated with this drug. II. Determine the 1-year survival rate and stable disease rate in patients treated with this drug. III. Determine the response or stable disease duration in patients treated with this drug. IV. Determine the toxicity of this drug in these patients. V. Determine the time to disease progression in patients treated with this drug. VI. Determine if changes in free VEGF Trap levels correlate with response or toxicity. OUTLINE: This is a multicenter, open-label study. Patients are stratified according to prior bevacizumab treatment (yes vs no). 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. Patients undergo blood collection at the beginning of each course and at 60 days after completion of study treatment. Samples are analyzed by immunoenzyme techniques to determine the pharmacokinetics of VEGF Trap. After completion of study treatment, patients are followed at 30 and 60 days and then every 3 months thereafter.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•histologically/cytologically confirmed metastatic colorectal metastatic cancer
•measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter) as\>20mm with conventional techniques or as \>10mm with spiral CT scan
•\>=4 weeks from major surgery
•at least 1prior line of systemic therapy for metastatic disease. Prior treatment with anti-epidermal growth factor receptor inhibitors is allowed. Last dose \>=4 weeks prior to randomization
•Two cohorts: 1) bevacizumab naïveand; 2) bevacizumab treated
•May have received prior thymidylate synthetase inhibitor concurrently with radiation as "radiation sensitizer". Last dose \>=4 weeks prior to randomization
•Prior radiation treatment \>=4 weeks prior to randomization
•Age\>=18 years
•Life expectancy \>=3 months
•ECOG\<=2 (Karnofsky=60%)
+12 more criteria

Exclusion Criteria

•chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to study entry
•Other investigational agents concurrently
•History of prior anti-angiogenic therapy other than bevacizumab
•Evidence of CNS disease
•Known hypersensitivity to Chinese hamster ovary cell products/other recombinant human antibodies, and patients with a history of allergic reactions attributed to compounds of similar chemical/biologic composition to other agents used in the study.
•Serious/non-healing wound/ulcer/bone fracture
•History of abdominal fistula/GI perforation/bowel obstruction/intraabdominal abscess within 28 days of treatment
•major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy
•anticipation of need for major surgical procedures during study
•core biopsy within 7 days prior to Day 1 therapy
+8 more criteria

Locations (1)

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Key Dates

Start Date

October 1, 2006

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

March 4, 2024

Enrollment

ACTUAL participants

Conditions

Recurrent Colon CancerRecurrent Rectal CancerStage IV Colon CancerStage IV Rectal Cancer

Interventions

aflibercept

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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