VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

NCT00407654 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00176PHL-050CDR0000518293N01CM62203
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer

Outcome Measures

Primary Outcomes (3)

• Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria)

  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

  Up to 6 years

• Progression-free Survival (Bevacizumab- naïve Group)

  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)

  4 months

• Progression-free Survival (Bevacizumab-treated Group)

  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)

  4 months

Secondary Outcomes (8)

• Overall Survival (Bevacizumab-naïve Group)

  12 months

• Overall Survival (Prior Bevacizumab Treated Group)

  12 months

• Time to Progression

  12 months

• Objective Stable Disease Rate

  Up to 6 years

• Number of Participants With Response (Bevacizumab-naïve Group)

  Up to 6 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

Drug: aflibercept

Interventions

aflibercept DRUG

Given intravenously

Also known as: vascular endothelial growth factor trap, VEGF Trap, Zaltrap, ziv-aflibercept

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)
• leukocytes \>3.0x10\^9/L
• absolute neutrophil count \>1.5 x 10\^9/L
• platelets\>75x10\^9/L
• INR \<1.5 unless on warfarin
• total bilirubin within 1.5xULN

You may not qualify if:

• 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
• Patients with clinically significant cardiovascular disease
• Evidence of bleeding diathesis or coagulopathy
• PT INR \>1.5 unless the patient is on full-dose warfarin
• Use of thrombolytic agents within 1 month of study initiation
• Significant Proteinuria (\>500mg/24h): Urine protein should be screened by random urinalysis for protein. If dipstick positive (\>1+), 24-hour urine protein should be obtained and if \>500mg/24 h, patient will be excluded.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. Malcolm Moore
• Organization: Princess Margaret Cancer Centre

malcolm.moore@uhn.ca

416-945-2263

Study Officials

• Malcolm Moore

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2006
• First Posted: December 5, 2006
• Study Start: October 1, 2006
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 4, 2024
• Results First Posted: August 18, 2015

Record last verified: 2024-02

Locations

CA (1)