Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00074321
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride — DRUG
    Given IV
  • oxaliplatin — DRUG
    Given IV
  • capecitabine — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. This phase I trial is studying the side effects and best dose of irinotecan, oxaliplatin, and capecitabine in treating patients with unresectable solid tumors.

Key Dates

Start date
Nov 30, 2003
Status verified
Jun 2013
Primary completion
Jul 31, 2010

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive irinotecan hydrochloride IV over 90 minutes and oxaliplatin IV over 2 hours on day 1 and capecitabine PO QD on days 2-15. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

MTD defined as one dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients) assessed using NCI CTCAE v3.0 [ Time Frame: 3 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MN

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