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

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04587128
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — DRUG
    Epidermal growth factor receptor inhibitor, anti-neoplastic
  • Cetuximab — DRUG
    Epidermal growth factor receptor inhibitor, anti-neoplastic
  • Irinotecan — DRUG
    anti-neoplastic, chemotherapy drug
  • FOLFIRI Protocol — DRUG
    folinic acid (also called leucovorin, calcium folinate or FA) fluorouracil (also called 5FU) irinotecan given per institutional standard (intravenously day 1 and day 15 of 28 day cycle) alternating and not concomitant with panitumumab or cetuximab
  • Bevacizumab — DRUG
    Bevacizumab (or biosimilar) may be administered with FOLFIRI per treating MD discretion and will be given per institutional standard (5 mg/kg intravenously day 1 and day 15 of 28 day cycle)

Study Details

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.

Key Dates

Start date
Oct 19, 2020
Status verified
Jun 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: No Previous EGFR
    Participant who have not be previously exposed to anti-EGFR therapies and are in the first or second-line metastatic treatment setting. Panitumumab (6mg/kg) or Cetuximab 500mg (per treating physician) on day 1 and 15 of a 28-day cycle
  • Experimental: Cohort B: Retreatment
    Participants with treatment refractory disease who have previously benefitted (greater than or equal to 4 months ago) from anti-EGFR therapy. Panitumumab (6mg/kg) or Cetuximab 500mg (per treating physician) on day 1 and 15 of a 28-day cycle, +/- Irinotecan (180mg/m\^2) every 2 two weeks per standard of care
  • Experimental: Cohort C: Rechallenge
    Participants with prior FOLFOX and either no prior EGFR inhibitor or treated on Cohort A. Alternating Panitumumab (6mg/kg) or Cetuximab 500mg (per treating physician) and 4 cycles of FOLFIRI +/- bevacizumab

Primary Outcome Measure

Disease Control Rate (DCR) at 6 months for Cohorts A and B [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

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By research site
University of Wisconsin Carbone Cancer Center· Madison, WI

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