Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC (NCT04587128) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC
United States34 participantsStarted 2020-10-19
Plain-language 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 71 participants with left-sided, unresectable metastatic CRC. Participants will be on study up to 5 years.
Who can participate
Age range18 Years
SexALL
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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 or neoadjuvant therapy.
* For Cohort B: Participants must have had at least stable disease (per treating 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 me…
What they're measuring
1
Disease Control Rate (DCR) at 6 months for Cohorts A and B