FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02508077
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Colorectal Carcinoma
  • Stage IVA Colorectal Cancer
  • Stage IVB Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Fluorouracil — DRUG
    Given IV
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Leucovorin Calcium — DRUG
    Given PO
  • Panitumumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well fluorouracil, leucovorin calcium, and irinotecan hydrochloride (FOLFIRI) together with panitumumab work in treating patients with colorectal cancer that expresses the RAS and B-Raf proto-oncogene, serine/threonine kinase (BRAF) wild-type genes, has spread from the original site of growth to another part of the body (metastatic), resists the effects of treatment with prior cetuximab (or panitumumab) plus irinotecan hydrochloride-based therapy, and who have failed at least one subsequent non-anti-epidermal growth factor receptor (EGFR) containing treatment regimen. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as panitumumab, may block tumor growth in different ways by targeting certain cells. Giving FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer.

Key Dates

Start date
Feb 16, 2016
Status verified
Jul 2018
Primary completion
Sep 13, 2017
Completion
Sep 13, 2017

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (panitumumab and FOLFIRI)
    Patients receive panitumumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium PO, and fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

4-month Progression-free Survival (PFS) Rate [ Time Frame: At 4 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
City of Hope Rancho CucamongaRancho CucamongaCalifornia91730-
South Pasadena Cancer CenterSouth PasadenaCalifornia91030-

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CACity of Hope Antelope Valley· Lancaster, CACity of Hope Rancho Cucamonga· Rancho Cucamonga, CASouth Pasadena Cancer Center· South Pasadena, CA

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