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

NCT04169347 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: Panit7156
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 8

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.

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (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.

  Through progression of disease, on average 6 months.

Secondary Outcomes (5)

• Evaluating progression free survival (PFS)

  Through progression of disease, on average 6 months.

• Evaluating overall survival (OS)

  Through progression of disease, on average 6 months.

• Evaluating toxicity of this regimen

  Through progression of disease, on average 6 months.

• Evaluating radiographic tumor regression

  Through progression of disease, on average 6 months.

• Evaluating for the velocity of tumor response to this regimen

  Patients will be followed until death or 5 years

Study Arms (1)

Active

OTHER

This is an open label study single arm

Drug: Oxaliplatin

Interventions

Oxaliplatin DRUG

2 week cycles

Also known as: Irinotecan, Leucovorin, Panitumumab

Active

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Criterium, Inc.: lead
• Amgen: collaborator

Study Sites (8)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Kansas University Cancer Center

Westwood, Kansas, 66205, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, 10016, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Interventions

Oxaliplatin; Irinotecan; Leucovorin; Panitumumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Howard Hochster, MD

  Lead Site PI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter open-label

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: November 19, 2019
• Study Start: December 2, 2019
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 27, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)