Genetic Testing Plus Irinotecan in Treating Patients With Solid Tumors or Lymphoma
A Phase I Clinical Trial to Investigate the Correlation Between UGT1A1 Genotype and Irinotecan (CPT-11) Pharmacokinetics and Toxicity in Cancer Patients
4 other identifiers
interventional
60
1 country
1
Brief Summary
Phase I trial to study genetic testing and the effectiveness of irinotecan in treating patients who have solid tumors and lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Genetic testing for a specific enzyme may help doctors determine whether side effects from or response to chemotherapy are related to a person's genetic makeup
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedJanuary 24, 2013
January 1, 2013
4.8 years
November 1, 1999
January 23, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Grade 3-4 diarrhea
A Cochran-Armitage test for trend will be used to determine whether there is a linear trend in the proportion of patients within each genotype experiencing grade 3-4 diarrhea. Similarly, trend analysis will be performed to determine if there is a linear trend in the proportion of patients within each phenotype experiencing grade 3-4 myelosuppression. Genotype (3 ordered levels) will be modeled as a function of metabolic ratios and biliary index to determine whether these are independent.
Up to 4 years
Secondary Outcomes (2)
Genotype
Up to 4 years
Phenotype
Up to 4 years
Study Arms (1)
Treatment (irinotecan hydrochloride)
EXPERIMENTALPatients receive irinotecan IV over 90 minutes once every 3 weeks. Treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- Histologically proven solid tumor or lymphoma
- Responded to irinotecan OR no existing curative therapy
- No leukemia
- Measurable or evaluable disease
- Performance status - Karnofsky 70-100%
- WBC at least 3500/mm\^3
- Absolute neutrophil count at least 1500/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin normal
- SGOT/SGPT less than 5 times upper limit of normal (unless due to disease)
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No inflammatory bowel disease requiring therapy
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Ratain
University of Chicago Comprehensive Cancer Center
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
November 1, 1999
First Posted
January 27, 2003
Study Start
January 1, 1999
Primary Completion
October 1, 2003
Last Updated
January 24, 2013
Record last verified: 2013-01