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

Phase 2
18 Years
Not Enrolling
Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

Thank you

Trial Information

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


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.


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.

Inclusion Criteria:

- Bilirubin =< 1.5 times upper limit of normal (ULN)

- AST/ALT =< 2.5 times ULN

- Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min

- Proteinuria =< 1+ by dipstick OR urine protein < 500 mg by 24-hour urine analysis

- No serious or nonhealing wound, ulcer, or bone fracture

- No abdominal fistula, gastrointestinal perforation, bowel obstruction, or
intra-abdominal abscess within the past 28 days

- At least 4 weeks since prior major surgical procedure or open biopsy

- Histologically or cytologically confirmed colorectal cancer

- No significant traumatic injury within the past 28 days

- Recovered from prior therapy

- Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1
dimension as >= 20 mm by conventional techniques or as >= 10 mm by spiral CT scan

- No prior surgery, radiation therapy, or radiofrequency ablation to the measurable

- Has received >= 1 prior systemic chemotherapy for metastatic disease AND has
documented radiological or clinical progression after the most recent therapy

- No CNS disease, including primary brain tumor or brain metastasis

- Life expectancy >= 3 months

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- No clinically significant cardiovascular disease, including, but not limited to, any
of the following: Peripheral vascular disease within the past 6 months (i.e.,
limiting activities of daily living or the presence of resting pain), Deep vein
thrombosis, pulmonary embolism, or other thromboembolic event within the past 6
months, Coronary artery bypass graft within the past 6 months, OR;

- OR; Unstable angina pectoris or myocardial infarction within the past 6 months, New
York Heart Association class III or IV congestive heart failure, Serious cardiac
arrhythmia requiring medication, Uncontrolled hypertension, defined as blood pressure
(BP) > 150/100 mm Hg OR systolic BP > 180 mm Hg (if diastolic BP < 90 mm Hg) within
the past 3 months

- No evidence of bleeding diathesis or coagulopathy

- No uncontrolled intercurrent illness including, but not limited to, any of the
following: Ongoing or active infection, Psychiatric illness or social situation that
would limit compliance with study requirements

- No active bleeding or pathological condition that carries a high risk of bleeding
(e.g., evidence of tumor invading major vessels by CT scan or known varices)

- No known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies

- No history of allergic reactions to compounds of similar chemical or biologic
composition to VEGF Trap or other agents used in this study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for >= 6 months after
completion of study treatment

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C),
prior thymidylate synthetase inhibitor (e.g., fluorouracil or capecitabine) allowed
as a radiosensitizer

- At least 4 weeks since prior radiation therapy of local disease, disease progression
must be documented afterwards

- At least 4 weeks since other prior anticancer agents

- At least 4 weeks since prior thrombolytic agents

- At least 7 days since prior core biopsy

- No prior antiangiogenic therapy (e.g., vascular endothelial growth factor tyrosine
kinase inhibitor) other than bevacizumab

- Prior anti-epidermal growth factor receptor inhibitors allowed

- No other concurrent investigational agents

- No concurrent antiretroviral therapy for HIV-positive patients

- No concurrent major surgery

- Concurrent full-dose anticoagulants (e.g., warfarin or low molecular weight heparin)
allowed provided dose is stable

- WBC >= 3,000/mm^3

- Absolute neutrophil count >= 1,500/mm^3

- Platelet count >= 75,000/mm^3

- INR =< 1.5 (=< 3 if on full-dose warfarin)

- Metastatic disease

- Concurrent antihypertensive medications allowed, unless dose and/or quantity has been
increased within the past 2 weeks

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective tumor response (defined as partial or complete response as defined by the RECIST criteria)

Outcome Time Frame:

Up to 6 years

Safety Issue:


Principal Investigator

Malcolm Moore

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

Related Keywords:

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms