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Colorectal Cancer MetastaticPhase 2NCT04169347

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

A Phase 2 study testing Oxaliplatin in people with Colorectal Cancer Metastatic, run by Criterium, Inc. at 8 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
8 sitesUnited States
Study dates
2 Dec 2019to Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have signed an approved informed consent.
  • Histologically confirmed diagnosis of advanced adenocarcinoma of the colon or rectum.
  • 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.
  • Bidimensionally measurable disease as defined in Section 3.3.1.
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  • 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)
  • ECOG Performance Status 0-1 (Appendix 1).
  • Recovery in full, from any previous surgical procedure.
  • 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.
  • Creatinine clearance ≥ 50 ml/min or serum creatinine ≤ 1.5 x upper limit of normal.
  • Bilirubin ≤ 1.5 x upper limit of normal
  • 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,
  • Albumin within normal institutional limits
  • Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal .
  • Absolute Neutrophil Count > 1500/mm3 and platelets > 100,000/mm3.

Who cannot join

  • 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.
  • Women who are pregnant or breastfeeding.
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • Subjects with >grade 1 neuropathy except for loss of tendon reflex.
  • Any active or uncontrolled infection.
  • Clinically significant cardiovascular disease (myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 6 months before enrollment
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  • 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
  • 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).
  • Clinically relevant interstitial lung disease (pneumonitis, pulmonary fibrosis, evidence of interstitial lung disease on baseline chest CT scan)
  • Allogeneic transplantation requiring immunosuppressive therapy.
  • Severe non-healing wounds, ulcers or bone fractures.
  • Evidence of bleeding diathesis or coagulopathy.
  • 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.
  • Concomitant therapy with certain anti-viral medicines (sorivudine and brivudine or analogue compounds).
  • 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.
  • Subjects with known allergy to the study drugs or to any of its metabolites.
  • Known DPD deficiency.
  • Current or recent (within the 28 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
  • Known grade III/IV allergic reaction against monoclonal antibodies.
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale Cancer Center

    New Haven, Connecticut, 06520

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Kansas University Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: Phase II Pilot Study of FOLFOXIRI Plus Panitumumab in Metastatic RAS Wild-type, Left-sided Colorectal Cancer

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.

Read the detailed description

This trial is designed to evaluate the efficacy of the combination of FOLFOXIRI and panitumumab as first-line therapy in patients with metastatic, left-sided, RAS WT CRC. The research hypothesis is that in this cohort of patients, the combination of triplet chemotherapy and anti-EGFR therapy will confer higher response rates and efficacy.

Being tested
Oxaliplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called Irinotecan, Leucovorin, Panitumumab

    2 week cycles

Study groups in NCT04169347
Study groupRoleWhat they receive
ActiveOtherThis is an open label study single arm
Receives: Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy/objective response rate

    Evaluate the efficacy/objective response rate of the combination of FOLFOXIRI and panitumumab as first-line therapy for metastatic left-sided, RAS WT CRC.

    Measured: Through progression of disease, on average 6 months.

Secondary outcomes (5)

  1. Evaluating progression free survival (PFS)

    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.

    Measured: Through progression of disease, on average 6 months.

  2. Evaluating overall survival (OS)

    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.

    Measured: Through progression of disease, on average 6 months.

  3. Evaluating toxicity of this regimen

    Subjects will be evaluated for toxicity/safety profile using CTCAE v4

    Measured: Through progression of disease, on average 6 months.

  4. Evaluating radiographic tumor regression

    Subjects will be evaluated for response according to the tumor response measured with RECIST v1.1a

    Measured: Through progression of disease, on average 6 months.

  5. Evaluating for the velocity of tumor response to this regimen

    Exploratory objectives include measuring circulating tumor DNA to assess for clinical response and velocity of response.

    Measured: Patients will be followed until death or 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start2 Dec 2019
  3. Primary completionDec 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multicenter open-label
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04169347
Sponsor's protocol ID
Panit7156
Status last verified
Dec 2022
First submitted
24 Sep 2019
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hochster HS, Blatchford PJ, Stein S, Lacy J, Kasi A, Boland PM, Gold P, Scott AJ, Oberstein P, Cusnir M, Rouse K, Mallalieu K, Saeed A; AGICC Group. FOLFOXIRI plus panitumumab for left-sided RAS-wild-type metastatic colorectal cancer. Oncologist. 2026 Aug 6;31(9):oyag320. doi: 10.1093/oncolo/oyag320.

    PubMed 42610703

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin in people with Colorectal Cancer Metastatic, run by Criterium, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy/objective response rate (time frame: Through progression of disease, on average 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04169347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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