This trial is active, not recruiting.

Condition advanced cancer
Treatment irinotecan
Phase phase 1
Sponsor University of Chicago
Start date February 2006
End date December 2016
Trial size 100 participants
Trial identifier NCT00708773, 13934B


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
irinotecan CPT-11
90 minute IV infusion once every 3 weeks. Dose will be based on sex and genotype determination.

Primary Outcomes

maximum tolerated dose
time frame: 3 weeks
dose-limiting toxicity
time frame: 3 weeks

Secondary Outcomes

time frame: 3 weeks
anti-tumor response
time frame: 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Phase I Genotype-Directed Dose-Escalation Study of Irinotecan (NSC616348, CPT-11, Camptosar) in Patients With Advanced Solid Tumors
Principal investigator Federico Innocenti, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Chicago.