Adjuvant Aflibercept for Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Aflibercept
Intervention description: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic; Colorectal; Colorectal Cancer; Resected or Ablated Metastatic Colorectal Cancer

Summary:

      The main purpose of this study is to evaluate if aflibercept can reduce the chance that
      metastatic (spread of) colorectal cancer can grow back after finishing standard treatment.
      The study will also look at the side effects of aflibercept and the effect on quality of
      life.
    

Eligibility criteria:

        Inclusion Criteria:

        3.1.1 First-line treatment of metastatic colorectal cancer with 3 or more metastases
        3.1.2At least 10 cycles of combination therapy with an oxaliplatin or irinotecan based
        regimen per institutional preference (patients may receive 6 cycles, go to surgery, then
        complete 4 cycles, they may complete all 10 (or more) prior to surgery, or receive any
        combination as long as they receive at least 10 cycles. ) 3.1.3 Resection or ablation of
        all metastatic sites that have not achieved complete response with perioperative therapy
        (regimen). The sequencing of resection, ablation, and 10-12 cycles of combination therapy
        (regimen) with an oxaliplatin or irinotecan based regimen may be performed according to
        standard institutional procedure.

        3.1.4 Patients achieving a complete response in a metastatic site by stereotactic body
        radiation are eligible if the site was not easily accessible by surgery or ablation and a
        complete response was achieved.

        3.1.5 No severe, uncontrolled concurrent illness that would interfere with protocol
        therapy.

        3.1.6 No known CNS disease 3.1.7 ECOG Performance Status 0-2 3.1.8 No chemotherapy or
        radiation therapy within last 3 weeks 3.1.9 For patients who had 3 months of perioperative
        therapy (regimen), then surgery, then 3 months of therapy (regimen), patients must be off
        therapy for no more than 8 weeks prior to randomization. For patients who had all their
        therapy and then surgery, they must be no more than 8 weeks from surgery prior to
        randomization.

        3.1.10 No concurrent anticancer therapy. 3.1.11 Absolute neutrophil count ≥ 1,500/uL, Hgb >
        9.0 g/dl, platelet ≥ 100,000/uL.

        3.1.12 Total bilirubin ≤ 1.5x upper limit of normal (ULN) and AST or ALT ≤ 5x ULN; 3.1.13
        Creatinine < 1.5 x ULN 3.1.14 Life expectancy of at least 12 weeks. 3.1.15 Age ≥ 18 years
        3.1.16 Women of childbearing potential must have a negative pregnancy test. 3.1.17 Men and
        women of childbearing potential must be willing to consent to using effective contraception
        while on treatment and for at least 3 months thereafter.

        3.1.18 Voluntary written informed consent.

        Exclusion Criteria:

        3.2.1 Residual metastatic disease after resection/ablation 3.2.2 Clinically significant
        cardiac disease (e.g., uncontrolled hypertension [blood pressure of >160/90 mmHg on
        medication], history of myocardial infarction within 6 months,), New York Heart Association
        (NYHA) Class II or greater congestive heart failure within 6 months, unstable arrhythmia.
        Patients with an atrial arrhythmia must have this condition well controlled on stable
        medication. Patients with current or recent (within 6 months) unstable angina are also not
        eligible. Documentation of cardiac medical history to be provided.

        3.2.3 Significant bleeding diathesis or coagulopathy 3.2.4 History of cerebral aneurysms or
        cerebral arteriovenous malformations. 3.2.5 Patients with recent (within 12 months)
        arterial thromboembolic events, including transient ischemic attack (TIA), cerebrovascular
        accident (CVA), or clinically significant peripheral artery disease should also be
        excluded.

        3.2.6 Patients with a history of a gastrointestinal fistula or perforation. 3.2.7 Women who
        are breast-feeding. 3.2.8 Patients who have undergone major surgery, chemotherapy, or
        radiotherapy within the last 3 weeks.

        3.2.9 Patients on concurrent anticancer therapy.