NCT00708773

Brief Summary

Describe the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of irinotecan in cancer patients with advanced solid tumors with UGT1A1 6/6 and 6/7 genotypes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

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

February 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

10.5 years

First QC Date

June 27, 2008

Last Update Submit

January 3, 2017

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

  • maximum tolerated dose

    3 weeks

  • dose-limiting toxicity

    3 weeks

Secondary Outcomes (2)

  • pharmacokinetics

    3 weeks

  • anti-tumor response

    6 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL
Drug: Irinotecan

Interventions

IrinotecanDRUG

90 minute IV infusion once every 3 weeks. Dose will be based on sex and genotype determination.

Also known as: CPT-11, Camptosar
Single Arm

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed solid tumor or lymphoma that is appropriate for treatment with irinotecan.
  • years or older
  • ECOG performance status 0-1
  • Life expectancy of greater than 12 weeks.
  • Normal organ and marrow function as defined below:
  • leukocytes ≥ 3,000/μl
  • absolute neutrophil count ≥ 1,500/μl
  • platelets ≥ 100,000/μl
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional ULN (≤5 X ULN in patients with hepatic metastases)
  • creatinine within normal institutional limits OR
  • glomerular filtration rate ≥50 ml/min/1.73 m2 for patients with creatinine levels above institutional normal as calculated by the modified MDRD equation recommended by the National Kidney Disease Education Program
  • Measurable or assessable disease.
  • Able to understand and the willing to sign a written informed consent document.
  • Women of child-bearing potential and men and their partners must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
  • +2 more criteria

You may not qualify if:

  • Biologic therapy, chemotherapy, radiotherapy, or investigational agent within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
  • Cannot be receiving any other investigational agents.
  • Use of colony growth factor within 3 week prior to study entry.
  • Post-transplant patients, as they may be subject to severe neutropenia.
  • Uncontrolled brain metastases. Patients with brain metastases must have stable neurologic status off of steroids and anticonvulsants for at least 4 weeks and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because irinotecan is an agent with the potential for teratogenic or abortifacient effects. Breastfeeding should be stopped.
  • HIV-positive patients, as patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  • History of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus.
  • Patients who have undergone a major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to start of therapy cannot participate.
  • Patients with prior pelvic irradiation cannot participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Chicago

Chicago, Illinois, 60637, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Interventions

Irinotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Federico Innocenti, MD, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 27, 2008

First Posted

July 2, 2008

Study Start

February 1, 2006

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

US(2)