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Genotype-Directed Dose-Escalation Study of Irinotecan in Patients With Advanced Solid Tumors

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT00708773
Collaborator
(none)
68
Enrollment
2
Locations
1
Arm
126
Duration (Months)
34
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Genotype-Directed Dose-Escalation Study of Irinotecan (NSC616348, CPT-11, Camptosar) in Patients With Advanced Solid Tumors
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Drug: Irinotecan
90 minute IV infusion once every 3 weeks. Dose will be based on sex and genotype determination.
Other Names:
  • CPT-11
  • Camptosar

    		•

    Outcome Measures

    Primary Outcome Measures

    1. maximum tolerated dose [3 weeks]

    2. dose-limiting toxicity [3 weeks]

    Secondary Outcome Measures

    1. pharmacokinetics [3 weeks]

    2. anti-tumor response [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed solid tumor or lymphoma that is appropriate for treatment with irinotecan.

    • 18 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.

    • Patients with UGT1A1 genotype 6/6, 6/7, and 7/7. Patients with either one or two of the rare alleles (i.e., 5 allele and 8 allele), and carriers of the *6 allele will not be enrolled in the study. Patients will have blood drawn for genotyping upon signing the informed consent form for this study.

    • Patients taking any statin therapy should interrupt the dosing of the statin for the 3 days before and after the administration of irinotecan at each cycle

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Chicago Chicago Illinois United States 60637
    2 NorthShore University HealthSystem Evanston Illinois United States 60201

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    • Principal Investigator: Federico Innocenti, MD, PhD, University of Chicago

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Chicago
    ClinicalTrials.gov Identifier:
    NCT00708773
    Other Study ID Numbers:
    • 13934B
    First Posted:
    Jul 2, 2008
    Last Update Posted:
    Jan 4, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Irinotecan

    Study Results

    No Results Posted as of Jan 4, 2017