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FOLFOXIRI Plus Panitumumab in Metastatic RAS Wild-type, Left-sided Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04169347
Recruitment Status : Recruiting
First Posted : November 19, 2019
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Criterium, Inc.

Brief Summary:
This is a phase II, open-label, non-randomized study in subjects with histologically confirmed diagnosis of left-sided RAS WT advanced adenocarcinoma of the colon or rectum who have not received prior systemic therapy for metastatic disease.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Study of FOLFOXIRI Plus Panitumumab in Metastatic RAS Wild-type, Left-sided Colorectal Cancer
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active
This is an open label study single arm
Drug: Oxaliplatin
2 week cycles
Other Names:
  • Irinotecan
  • Leucovorin
  • Panitumumab




Primary Outcome Measures :
  1. Efficacy/objective response rate [ Time Frame: Through progression of disease, on average 6 months. ]
    Evaluate the efficacy/objective response rate of the combination of FOLFOXIRI and panitumumab as first-line therapy for metastatic left-sided, RAS WT CRC.


Secondary Outcome Measures :
  1. Evaluating progression free survival (PFS) [ Time Frame: Through progression of disease, on average 6 months. ]
    The secondary efficacy endpoints include time to progression and overall survival. Kaplan-Meier estimates will be calculated for time to progression and overall survival, and medians, along with two-sided 95% confidence intervals, will be reported.

  2. Evaluating overall survival (OS) [ Time Frame: Through progression of disease, on average 6 months. ]
    The secondary efficacy endpoints include time to progression and overall survival. Kaplan-Meier estimates will be calculated for time to progression and overall survival, and medians, along with two-sided 95% confidence intervals, will be reported.

  3. Evaluating toxicity of this regimen [ Time Frame: Through progression of disease, on average 6 months. ]
    Subjects will be evaluated for toxicity/safety profile using CTCAE v4

  4. Evaluating radiographic tumor regression [ Time Frame: Through progression of disease, on average 6 months. ]
    Subjects will be evaluated for response according to the tumor response measured with RECIST v1.1a

  5. Evaluating for the velocity of tumor response to this regimen [ Time Frame: Patients will be followed until death or 5 years ]
    Exploratory objectives include measuring circulating tumor DNA to assess for clinical response and velocity of response.



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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. Subjects must have signed an approved informed consent.
  2. Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum.
  3. No previous systemic chemotherapy for metastatic disease

    • Subjects who have had prior adjuvant chemotherapy for non-metastatic disease are eligible if more than six months have elapsed after completing therapy
    • Subjects treated with adjuvant chemotherapy who relapse within six months after completion will not be eligible.
  4. Bidimensionally measurable disease as defined in Section 3.3.1.
  5. RAS wild-type tested in

    • KRAS exon 2 (codons 12/13)
    • KRAS exon 3 (codons 59/61)
    • KRAS exon 4 (codons 117/146)
    • NRAS exon 2 (codons 12/13)
    • NRAS exon 3 (codons 59/61)
    • NRAS exon 4 (codons 117/146)
  6. ECOG Performance Status 0-1 (Appendix 1).
  7. Recovery in full, from any previous surgical procedure.
  8. Subjects >=18 years of age. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 6 months after the study in such a manner that the risk of pregnancy is minimized.

    WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal.

    WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.

  9. Creatinine clearance ≥ 50 ml/min or serum creatinine ≤ 1.5 x upper limit of normal.
  10. Bilirubin ≤ 1.5 x upper limit of normal
  11. AST, ALT ≤ 2.5 x upper limit of normal in absence of liver metastases, or ≤ 5 x upper limit of normal in presence of liver metastases,
  12. Albumin within normal institutional limits
  13. Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal .
  14. Absolute Neutrophil Count > 1500/mm3 and platelets > 100,000/mm3.

Exclusion Criteria:

  1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 months after the study. Subjects who are men must also agree to use effective contraception.
  2. Women who are pregnant or breastfeeding.
  3. Women with a positive pregnancy test on enrollment or prior to study drug administration.
  4. Subjects with >grade 1 neuropathy except for loss of tendon reflex.
  5. Any active or uncontrolled infection.
  6. Clinically significant cardiovascular disease (myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrollment
  7. Past or current history of malignancies except for the indication under this study and curatively treated:

    • Basal and squamous cell carcinoma of the skin
    • In-situ carcinoma of the cervix
    • Other malignant disease without recurrence after at least 3 years of follow-up
  8. History or evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumor, seizure not controlled with standard medical therapy, brain metastases or history of stroke).
  9. Clinically relevant interstitial lung disease (pneumonitis, pulmonary fibrosis, evidence of interstitial lung disease on baseline chest CT scan)
  10. Allogeneic transplantation requiring immunosuppressive therapy.
  11. Severe non-healing wounds, ulcers or bone fractures.
  12. Evidence of bleeding diathesis or coagulopathy.
  13. Patients not receiving therapeutic anticoagulation must have an INR < 1.5 x ULN and aPTT < 1.5 x ULN within 7 days prior to randomization. The use of full-dose anticoagulants is allowed as long as the INR or aPTT is within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose for anticoagulants for at least two weeks.
  14. Concomitant therapy with certain anti-viral medicines (sorivudine and brivudine or analogue compounds).
  15. Major surgical procedure, open biopsy, nor significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study except for surgery for colorectal cancer with curative intent and central venous line placement for chemotherapy administration.
  16. Subjects with known allergy to the study drugs or to any of its metabolites.
  17. Known DPD deficiency.
  18. Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
  19. Known grade III/IV allergic reaction against monoclonal antibodies.
  20. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.

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): NCT04169347


Contacts
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Contact: Eduardo F Jahn 5185389741 Panit7156PM@criteriuminc.com

Locations
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United States, Arizona
University of Arizona Cancer Center Not yet recruiting
Tucson, Arizona, United States, 85724
Contact: Aaron Scott, MD    520-891-0957    ajscott9665@gmail.com   
Contact: Jaron Solsky    520-626-9001    solsky@email.arizona.edu   
Principal Investigator: Aaron Scott, MD         
United States, Kansas
Kansas University Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Anwaar Saeed, MD    816-898-9413    asaeed@kumc.edu   
Contact: Benjamin Roberts, BS    913-588-6939    broberts4@kumc.edu   
Principal Investigator: Anwaar Saeed, MD         
United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: HOWARD HOCHSTER, MD    212-333-7775    hh458@cinj.rutgers.edu   
Contact: SUTIRTHA DATTA    732-235-8996    sd1200@cinj.rutgers.edu   
Principal Investigator: Howard Hochster, MD         
Sponsors and Collaborators
Criterium, Inc.
Amgen
Investigators
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Principal Investigator: Howard Hochster, MD Lead Site PI
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Responsible Party: Criterium, Inc.
ClinicalTrials.gov Identifier: NCT04169347    
Other Study ID Numbers: Panit7156
First Posted: November 19, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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
Leucovorin
Oxaliplatin
Irinotecan
Panitumumab
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Antineoplastic Agents, Immunological