NCT00654160

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan when given together with fluorouracil and leucovorin in treating patients with advanced gastrointestinal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2008

Longer than 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

First Submitted

Initial submission to the registry

April 4, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2012

Completed
Last Updated

May 25, 2017

Status Verified

September 1, 2016

Enrollment Period

2.4 years

First QC Date

April 4, 2008

Last Update Submit

May 23, 2017

Conditions

Anal CancerCarcinoma of the AppendixColorectal CancerEsophageal CancerExtrahepatic Bile Duct CancerGallbladder CancerGastric CancerGastrointestinal Carcinoid TumorGastrointestinal Stromal TumorLiver CancerPancreatic CancerSmall Intestine Cancer

Keywords

stage IIIB anal cancerstage IV anal cancerrecurrent anal cancercarcinoma of the appendixstage III colon cancerstage IV colon cancerrecurrent colon cancerstage III rectal cancerstage IV rectal cancerrecurrent rectal cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal cancerrecurrent extrahepatic bile duct cancerunresectable extrahepatic bile duct cancerunresectable gallbladder cancerrecurrent gallbladder cancerstage III gastric cancerstage IV gastric cancerrecurrent gastric cancermetastatic gastrointestinal carcinoid tumorrecurrent gastrointestinal carcinoid tumorregional gastrointestinal carcinoid tumorgastrointestinal stromal tumoradvanced adult primary liver cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent pancreatic cancerrecurrent small intestine cancersmall intestine adenocarcinomasmall intestine leiomyosarcomasmall intestine lymphoma

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of genotype-based dosing of FOLFIRI with or without monoclonal antibody therapy

Secondary Outcomes (1)

  • Response rate of genotype-based dosing in the subset of patients that has colorectal cancer

Interventions

fluorouracilDRUG
irinotecan hydrochlorideDRUG
leucovorin calciumDRUG
pharmacogenomic studiesOTHER
pharmacological studyOTHER

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Life expectancy ≥ 12 weeks.
  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • SGOT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN if liver metastases)
  • Total Bilirubin ≤ ULN for patients in group 3 and ≤ 2.0 times ULN for patients in groups 1 and 2
  • Hemoglobin ≥ 9.0 g/dL
  • Creatinine ≤ 1.5 times ULN or creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for the duration of study treatment
  • Willing to provide blood samples for mandatory translational studies

You may not qualify if:

  • Known allergy to irinotecan hydrochloride-related agents (e.g., topotecan), 5-fluorouracil, and/or leucovorin calcium
  • Active or uncontrolled infection
  • Evidence of serious intercurrent illness (e.g., unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
  • PRIOR CONCURRENT THERAPY:
  • Recovered from all toxicities
  • More than 4 weeks since prior major surgery
  • More than 2 weeks since completion of prior radiotherapy
  • No prior radiotherapy to \> 25% of bone marrow
  • More than 2 week since prior cytotoxic chemotherapy, biologic therapy, or immunotherapy
  • No concurrent sargramostim (GM-CSF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anus NeoplasmsAppendiceal NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsGastrointestinal Stromal TumorsLiver NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, Hepatocellular

Interventions

FluorouracilIrinotecanLeucovorinPharmacogenomic Testing

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesCecal NeoplasmsCecal DiseasesColonic DiseasesHead and Neck NeoplasmsEsophageal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeLiver DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesGenetic TestingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Robert McWilliams, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 7, 2008

Study Start

June 1, 2008

Primary Completion

November 1, 2010

Study Completion

December 3, 2012

Last Updated

May 25, 2017

Record last verified: 2016-09

Locations

US(1)