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

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ClinicalTrials.gov Identifier: NCT01057017
Recruitment Status : Terminated (possible lack of efficacy)
First Posted : January 27, 2010
Results First Posted : November 4, 2013
Last Update Posted : April 24, 2019
Sponsor:
Collaborators:
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Biological: intervention Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Panitumumab and Bevacizumab Maintenance After First-Line FOLFOX-Bevacizumab for Patients With Advanced Colorectal Cancer With Wild-Type Ras
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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:
  • 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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057017


Locations
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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
Rhode Island Hospital
The Miriam Hospital
Investigators
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Principal Investigator: howard p safran, MD lifespan Hospitals

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Responsible Party: howard safran, Director of BrUOG, Brown University
ClinicalTrials.gov Identifier: NCT01057017     History of Changes
Other Study ID Numbers: BrUOG-CR-218
First Posted: January 27, 2010    Key Record Dates
Results First Posted: November 4, 2013
Last Update Posted: April 24, 2019
Last Verified: April 2019
Keywords provided by howard safran, Brown University:
colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Panitumumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors