Selumetinib and Cetuximab in Treating Patients With Refractory Solid Tumors

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01217450
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • selumetinib — DRUG
    Given orally
  • cetuximab — BIOLOGICAL
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase I trial is studying the side effects and the best dose of MEK Inhibitor AZD6244 when given together with cetuximab in patients with advanced or refractory solid tumors that cannot be removed by surgery. MEK inhibitor AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving MEK Inhibitor AZD6244 together with cetuximab may kill more tumor cells.

Key Dates

Start date
Oct 31, 2012
Status verified
Dec 2013
Primary completion
Dec 31, 2012
Completion
May 31, 2014

Study Design

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

Arms

  • Experimental: Treatment (selumetinib, cetuximab)
    Patients receive oral MEK inhibitor AZD6244 once or twice daily on days 1-28 and cetuximab IV over 60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD of selumetinib combined with cetuximab [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
National Cancer Institute Medicine BranchBethesdaMaryland20892-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-
Wisconsin Clinical Cancer CenterMilwaukeeWisconsin53226-

Find similar trials in Bethesda, MD

By research site
National Cancer Institute Medicine Branch· Bethesda, MDUniversity of Wisconsin Hospital and Clinics· Madison, WIWisconsin Clinical Cancer Center· Milwaukee, WI

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