Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery

Part of paid clinical trials in Corona, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03317119
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Colon Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Rectal Carcinoma
  • RAS Family Gene Mutation
  • Stage III Colon Cancer AJCC v7
  • Stage III Colorectal Cancer AJCC v7
  • Stage III Rectal Cancer AJCC v7
  • Stage IIIA Colon Cancer AJCC v7
  • Stage IIIA Colorectal Cancer AJCC v7
  • Stage IIIA Rectal Cancer AJCC v7
  • Stage IIIB Colon Cancer AJCC v7
  • Stage IIIB Colorectal Cancer AJCC v7
  • Stage IIIB Rectal Cancer AJCC v7
  • Stage IIIC Colon Cancer AJCC v7
  • Stage IIIC Colorectal Cancer AJCC v7
  • Stage IIIC Rectal Cancer AJCC v7
  • Stage IV Colon Cancer AJCC v7
  • Stage IV Colorectal Cancer AJCC v7
  • Stage IV Rectal Cancer AJCC v7
  • Stage IVA Colon Cancer AJCC v7
  • Stage IVA Colorectal Cancer AJCC v7
  • Stage IVA Rectal Cancer AJCC v7
  • Stage IVB Colon Cancer AJCC v7
  • Stage IVB Colorectal Cancer AJCC v7
  • Stage IVB Rectal Cancer AJCC v7

Eligibility Criteria

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

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Trametinib — DRUG
    Given PO
  • Trifluridine and Tipiracil Hydrochloride — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as trifluridine and tipiracil 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 trametinib and trifluridine and tipiracil hydrochloride may prevent cancer cells from dividing and work better in treating patients with colon and rectal cancer.

Key Dates

Start date
Apr 11, 2018
Status verified
Apr 2024
Primary completion
Jul 14, 2023
Completion
Jul 14, 2023

Study Design

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

Arms

  • Experimental: Treatment (TAS-102, trametinib)
    Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12 and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose defined for the combination of trametinib, and Trifluridine and Tipiracil Hydrochloride (TAS?102) as the highest dose level at which 0-1 out of 6 patients experience dose limiting toxicities [ Time Frame: Up to 28 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope CoronaCoronaCalifornia92879-
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
City of Hope Mission HillsMission HillsCalifornia91345-
City of Hope Rancho CucamongaRancho CucamongaCalifornia91730-
City of Hope - Santa ClaritaSanta ClaritaCalifornia91355-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
City of Hope West CovinaWest CovinaCalifornia91790-

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By research site
City of Hope Corona· Corona, CACity of Hope Medical Center· Duarte, CACity of Hope Antelope Valley· Lancaster, CACity of Hope Mission Hills· Mission Hills, CACity of Hope Rancho Cucamonga· Rancho Cucamonga, CACity of Hope - Santa Clarita· Santa Clarita, CA

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