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

February 13, 2020 updated by: howard safran, Brown University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Biological: intervention
Other Names:
  • Panitumumab
  • Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Toxicity to Combination of Panitumumab and Bevacizumab
Time Frame: every 3 weeks until patient comes off study (progressive disease), for up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Miriam Hospital
Rhode Island Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: howard p safran, MD, Lifespan Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BrUOG-CR-218

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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