First-Line FOLFOX-Bevacizumab for Advanced Colorectal Cancer With Wild-Type Ras

NCT ID: NCT01057017

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-12-31

Brief 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.

Detailed Description

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention

Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.

Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression

Group Type: EXPERIMENTAL

intervention

Intervention Type: BIOLOGICAL

Interventions

intervention

Intervention Type: BIOLOGICAL

Other Intervention Names

Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.; Panitumumab; Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression; Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

howard safran

Director of BrUOG

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

howard p safran, MD

Role: PRINCIPAL_INVESTIGATOR

lifespan Hospitals

Locations

Rhode Island Hospital

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

BrUOG-CR-218

Identifier Type: -

Identifier Source: org_study_id