Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC

  • STATUS
    Recruiting
  • End date
    Oct 27, 2025
  • participants needed
    110
  • sponsor
    University of Wisconsin, Madison
Updated on 27 June 2021

Summary

The study will use previously established doses of panitumumab or cetuximab in the metastatic setting for the treatment of unresectable colorectal cancer (CRC). It is designed to investigate an alternative treatment strategy to maximize the benefit to inhibition of epidermal growth factor receptor (EGFR) for a highly selected patient population. It will enroll 110 participants with left-sided, unresectable metastatic CRC. Participants will be on study up to 5 years.

Details
Condition Metastatic Colorectal Cancer
Treatment Panitumumab, Cetuximab, Irinotecan
Clinical Study IdentifierNCT04587128
SponsorUniversity of Wisconsin, Madison
Last Modified on27 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information
As determined by the enrolling physician or protocol designee, ability of the participant to understand and comply with study procedures for the entire length of the study
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
Have a diagnosis of histologically confirmed metastatic colorectal cancer with primary tumor located beyond the splenic flexure. Histologic confirmation of a colorectal primary tumor is acceptable if accompanied by radiographic evidence of metastatic disease
For Cohort A: Participants must enroll for study treatment in the first or second-line metastatic setting. Participants may receive 1 month of standard chemotherapy in the metastatic setting and still be eligible to initiate protocol therapy in the first-line setting. Adjuvant or neoadjuvant therapy does not count as a line of therapy even if given in the setting of metastatic disease (oligometastatic), unless disease recurrence was noted within 6 months of completing the last dose of the adjuvant of neoadjuvant therapy
For Cohort B: Participants must have had at least stable disease (per treatment physician) on a prior EGFR inhibitor containing regimen and it must be at least 4 months since the prior anti-EGFR inhibitor treatment was completed. Participants previously enrolled in Cohort A can later enroll in Cohort B should the eligibility criteria be met
Evaluable disease according to RECIST v1.1. Participants do not have to have measureable disease
Participants with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for 2 weeks, and are asymptomatic
Demonstrate adequate organ function; all screening labs to be obtained within 7 days prior to registration. Note minimum platelet requirement differs between Cohort A and B
Females of childbearing potential must have a negative serum pregnancy test within 7 days of registration and not be breastfeeding. Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
Absolute Neutrophil Count (ANC) 1,000 / mcL
Females of childbearing potential and males must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method
Platelets 50,000 / mcL (Cohort A); 75,000 mcL (Cohort B)
Tumor must be mismatch repair (MMR) proficient as determined by microsatellite instability or immunohistochemistry for MMR proteins
Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) 2.0 X upper limit of normal (ULN) OR 60 mL/min for subject with creatinine levels > 2.0 X institutional ULN
Bilirubin 1.5 ULN OR direct bilirubin ULN for subjects with bilirubin levels >1.5 x ULN
Microsatellite instability (MSI) testing must be MSI-stable or MSI-low
Or IHC for MMR proteins must demonstrate intact MMR proteins
Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) 5 ULN
Standard tumor molecular profiling with no pathologic variants in KRAS or NRAS or BRAF V600 mutations
Albumin 2.5 mg/dL
Participants must not have known additional malignancy that is requiring systemic treatment. Participants taking hormonal treatments for breast or prostate cancer are still eligible
No major surgery within prior 2 weeks of treatment initiation
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to panitumumab or cetuximab, including known severe hypersensitivity reactions to monoclonal antibodies
Participants must have no metastatic cancer lesions greater than 3.5cm in diameter. Any number of metastatic lesions will be allowed
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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