First-Line FOLFOX-Bevacizumab for Advanced Colorectal Cancer With Wild-Type Ras
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: intervention
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colorectal cancer

Summary:

      Bevacizumab given at 7.5mg/kg. IV over 10-90 minutes every 3 weeks until disease
      progression.Panitumumab given at 9mg/kg. IV over 30-90 minutes every 3 weeks until disease
      progression.Primary Objective: To determine the safety of every 3 week panitumumab and
      bevacizumab as maintenance therapy for patients with metastatic colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or pathologically confirmed advanced colorectal cancer who received
             FOLFOX/bevacizumab for first-line treatment of metastatic disease.

          2. Patients must not have had disease progression while receiving a minimum of 6
             treatments of FOLFOX/bevacizumab. Patients with stable or responding disease on
             FOLFOX/bevacizumab are eligible. Bevacizumab does not need to be administered with all
             cycles of FOLFOX.

          3. At least 3 weeks since prior FOLFOX/bevacizumab.

          4. Wild type ras

          5. No potentially curative treatment option.

          6. ECOG performance status 0-1

          7. Age>18, not pregnant or breast-feeding

          8. Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥
             1500/µl; platelet count ≥ 100,000/µl, Creatinine ≤ 2.0 mg/dl, Bilirubin ≤ 1.5 x upper
             limit of normal, AST ≤ 3 x upper limit of normal (or ≤ 5 x upper limit of normal for
             patients with liver metastases), Magnesium > lower limit of normal

          9. Life expectancy of at least 16 weeks

         10. Must not have uncontrolled severe, intercurrent illness.

         11. No chemotherapy or radiation therapy within last 3 weeks

         12. No concurrent anticancer therapy.

         13. Signed study-specific consent form prior to study entry

        Exclusion Criteria:

          1. Prior EGFR inhibitor and prior irinotecan.

          2. Clinically significant cardiac disease (e.g., uncontrolled hypertension [blood
             pressure of >150/90 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.

          3. Significant bleeding diathesis or coagulopathy

          4. Major surgical procedure within 28 days prior to start of treatment. Port-a-cath
             placements are allowed.

          5. Serious, nonhealing wound, ulcer, or current healing fracture

          6. History of cerebral aneurysms or cerebral arteriovenous malformations.

          7. 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.

          8. Brain metastases

          9. Patients with a history of a gastrointestinal fistula or perforation.

         10. Significant infection or other coexistent medical condition that would preclude
             protocol therapy.

         11. Interstitial lung disease

         12. Patients who have had an organ transplant

         13. Known positive test(s) for HIV infection, hepatitis C virus, acute or chronic active
             hepatitis B infection

         14. Women of childbearing potential and men who are sexually active and not willing/able
             to use medically acceptable forms of contraception; this exclusion is necessary
             because the treatment involved in this study may be significantly teratogenic.

         15. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free
             for a minimum of 2 years (For example, carcinoma in situ of the breast, bladder and
             cervix are permissible).