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Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras

26 patients with advanced colorectal cancer will be given Bevacizumab 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

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).

Type of Study:


Study Design:

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

Outcome Measure:

Response rate

Outcome Time Frame:

On treatment until progression

Safety Issue:


Principal Investigator

howard p safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

lifespan Hospitals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2010

Completion Date:

December 2011

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • Colorectal Neoplasms



Rhode Island Hospital Providence, Rhode Island  02903