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Recurrent Colon CancerPhase 2NCT00407654

VEGF Trap in Treating Patients With Previously Treated Metastatic Colorectal Cancer

A Phase 2 study testing aflibercept in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by National Cancer Institute (NCI) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteCanada
Study dates
Oct 2006to Sep 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • AST/ALT≤2.5 X institution ULN
  • creatinine≤1.5xULN OR creatinine clearance >60mL/min/1.73m2 for patients with creatinine levels above1.5x institution limits
  • Urinalysis negative for protein OR 24h urine for protein <500 mg
  • full-dose anticoagulants with PT INR >1.5 eligible provided that: a) patient is therapeutic on stable dose of warfarin or low molecular weight heparin; b) patients on warfarin, the upper target for INR is <=3; c) no active bleeding/pathological condition carrying high bleeding risk
  • Eligibility of patients receiving medications known to affect activity/PK of VEGF Trap will be determined by PI
  • Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 6 months after completion of VEGF Trap therapy
  • Ability to understand/willingness to sign written informed consent

Who cannot join

  • 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
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  • 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.
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study
  • Pregnant women
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for PK interactions with VEGF Trap

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network-Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
aflibercept
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • afliberceptDrug

    Also called vascular endothelial growth factor trap, VEGF Trap, Zaltrap, ziv-aflibercept

    Given intravenously

Study groups in NCT00407654
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: aflibercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 6 years

  2. 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)

    Measured: 4 months

  3. 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)

    Measured: 4 months

Secondary outcomes (8)

  1. Overall Survival (Bevacizumab-naïve Group)

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

    Measured: 12 months

  2. Overall Survival (Prior Bevacizumab Treated Group)

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

    Measured: 12 months

  3. Time to Progression

    Kaplan-Meier method will be used.

    Measured: 12 months

  4. Objective Stable Disease Rate

    Measured: Up to 6 years

  5. Number of Participants With Response (Bevacizumab-naïve Group)

    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

    Measured: Up to 6 years

  6. Overall Survival (Bevacizumab-treated Group)

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

    Measured: 6 months

  7. Overall Survival (Bevacizumab-treated Group)

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

    Measured: 12 months

  8. Number of Participants With Response (Bevacizumab-treated Group)

    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

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00407654
Sponsor's protocol ID
NCI-2009-00176
Other IDs
PHL-050, CDR0000518293, N01CM62203
Status last verified
Feb 2024
First submitted
4 Dec 2006
Last updated
4 Mar 2024
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aflibercept in people with Recurrent Colon Cancer and Recurrent Rectal Cancer, run by National Cancer Institute (NCI) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Tumor Response (Defined as Partial or Complete Response as Defined by the RECIST Criteria) (time frame: Up to 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00407654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.

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