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

NCT01057017 | Terminated Phase 2 Results DMC

• 1 other identifier: BrUOG-CR-218
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab

  To determine the safety of every 3 week panitumumab and bevacizumab as maintenance therapy for patients with metastatic colorectal cancer. Use of CTCAE version 3

  every 3 weeks until patient comes off study (progressive disease), for up to 2 years

Study Arms (1)

intervention

EXPERIMENTAL

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

Biological: intervention

Interventions

intervention BIOLOGICAL

Also known as: 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

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or pathologically confirmed advanced colorectal cancer who received FOLFOX/bevacizumab for first-line treatment of metastatic disease.
• 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.
• At least 3 weeks since prior FOLFOX/bevacizumab.
• Wild type ras
• No potentially curative treatment option.
• ECOG performance status 0-1
• Age\>18, not pregnant or breast-feeding
• 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
• Life expectancy of at least 16 weeks
• Must not have uncontrolled severe, intercurrent illness.
• No chemotherapy or radiation therapy within last 3 weeks
• No concurrent anticancer therapy.
• Signed study-specific consent form prior to study entry

You may not qualify if:

• Prior EGFR inhibitor and prior irinotecan.
• 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.
• Significant bleeding diathesis or coagulopathy
• Major surgical procedure within 28 days prior to start of treatment. Port-a-cath placements are allowed.
• Serious, nonhealing wound, ulcer, or current healing fracture
• History of cerebral aneurysms or cerebral arteriovenous malformations.
• 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.
• Brain metastases
• Patients with a history of a gastrointestinal fistula or perforation.
• Significant infection or other coexistent medical condition that would preclude protocol therapy.
• Interstitial lung disease
• Patients who have had an organ transplant
• Known positive test(s) for HIV infection, hepatitis C virus, acute or chronic active hepatitis B infection
• 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).

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Methods; Bevacizumab; Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

Hsafran@lifespan.org

4018633000

Study Officials

• howard p safran, MD

  lifespan Hospitals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of BrUOG

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 27, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 17, 2020
• Results First Posted: November 4, 2013

Record last verified: 2020-02

Locations

US (1)