NCT00074321

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

6.7 years

First QC Date

December 10, 2003

Last Update Submit

June 5, 2013

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

  • 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

    3 weeks

Secondary Outcomes (9)

  • Incidence of UTG1A1*28 polymorphism

    Up to 3 months

  • Adverse events profile assessed using NCI CTCAE v3.0

    Up to 3 months

  • Toxicity profile assessed using NCI CTCAE v3.0

    Up to 3 months

  • Response profile using RECIST criteria

    Up to 3 months

  • Time until any treatment related toxicity

    Up to 3 months

  • +4 more secondary outcomes

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: irinotecan hydrochlorideDrug: oxaliplatinDrug: capecitabineOther: laboratory biomarker analysisOther: pharmacological study

Interventions

irinotecan hydrochlorideDRUG

Given IV

Also known as: Campto, Camptosar, CPT-11, irinotecan, U-101440E
Arm I
oxaliplatinDRUG

Given IV

Also known as: 1-OHP, Dacotin, Dacplat, Eloxatin, L-OHP
Arm I
capecitabineDRUG

Given PO

Also known as: CAPE, Ro 09-1978/000, Xeloda
Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy
  • Unresectable disease
  • Willing to provide biologic specimens to determine UGT1A1 genotype
  • No CNS metastases
  • Prior CNS metastases allowed provided patient was treated with surgery and/or radiotherapy and is stable for more than 8 weeks
  • Performance status - ECOG 0-2
  • At least 12 weeks
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9.0 g/dL
  • Bilirubin no greater than upper limit of normal (ULN) for patients with 6/6 UGT1A1 genotype (1.5 times ULN for patients with 6/7 \[closed to accrual as of 8/24/06\] or 7/7 UGT1A1 genotype)
  • AST no greater than 3 times ULN (5 times ULN if there is liver involvement)
  • Creatinine no greater than 1.5 times ULN
  • No New York Heart Association class III or IV heart disease
  • Not pregnant or nursing
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

IrinotecanOxaliplatinCapecitabine

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsCoordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Matthew Goetz

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

November 1, 2003

Primary Completion

July 1, 2010

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)