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Irinotecan in Treating Asian Patients With Solid Tumors

Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00731276
Enrollment
18
Registered
2008-08-08
Start date
2008-04-03
Completion date
2016-04-30
Last updated
2017-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Brief summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan in treating Asian patients with solid tumors.

Detailed description

OBJECTIVES: Primary * To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan hydrochloride according to the genotype status of Asian patients with solid tumors. Secondary * To investigate the pharmacokinetics of irinotecan hydrochloride and its metabolites SN-38 and SN-38G. * To evaluate time to tumor response, response duration, and time to progression in these patients. OUTLINE: Patients are stratified according to genotype status (UGT1A1\*28 vs UGT1A1\*6) Patients receive irinotecan hydrochloride IV once weekly for 3 weeks. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic, and pharmacodynamic studies.

Interventions

DRUGirinotecan hydrochloride
OTHERpharmacogenomic studies
OTHERpharmacological study

Sponsors

National Cancer Centre, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumors * Failed at least one line of prior chemotherapy * Must belong to either Chinese, Malay, or Indian ethnic groups * Previously irradiated disease allowed provided marker lesions not within the irradiated field * Presence of at least one bidimensionally measurable, non-CNS indicator lesion, defined by radiologic study (including CT or MRI scan, ultrasound, or chest X-ray) or physical exam, meeting 1 of the following criteria: * Measurable disease on CT or MRI scan must have one diameter ≥ 1 cm and one diameter ≥ 2 cm * Measurable disease on chest X-ray or ultrasound must have both diameters ≥ 2 cm * Palpable tumor masses that cannot be evaluated radiologically must have two diameters ≥ 2 cm * Measurable skin lesion must have at least one diameter ≥ 1 cm * No unidimensionally measurable or evaluable only disease * No known brain or leptomeningeal metastasis * No uncontrolled large pleural effusions PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute granulocyte count ≥ 1,000/µL * WBC ≥ 3,500/µL * Hemoglobin ≥ 9 g/dL * Platelet count ≥ 100,000/µL * Serum total bilirubin ≤ 2.0 mg/dL * ALT/AST \< 2.5 times normal (5 times normal in patients with known metastatic disease in the liver) * Creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical problems severe enough to prevent compliance with the study requirements * No prior malignancies, except for adequately treated basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or other cancer for which the patient has been disease-free for 5 years * No active or uncontrolled infection * No pre-existing cardiac disease, including congestive heart failure, arrhythmia requiring treatment, or myocardial infarction within the past 3 months * No pneumonitis * No uncontrolled diabetes mellitus (i.e., random blood glucose \> 200 mg/dL) * No inflammatory bowel disease PRIOR CONCURRENT THERAPY: * At least 1 week since prior and no concurrent ketoconazole * More than 4 weeks since prior chemotherapy or radiotherapy * At least 2 weeks since prior and no concurrent Hypericum perforatum (St. John wort) * No prior irinotecan hydrochloride * No concurrent investigational antineoplastic therapy or other investigational drugs

Design outcomes

Primary

MeasureTime frame
Dose-limiting toxicityNo time frame defined. Trial is still recruiting.
Maximum tolerated doseNo time frame defined. Trial is still recruiting.

Secondary

MeasureTime frame
PharmacokineticsNo time frame defined. Trial is still recruiting.
Time to tumor responseNo time frame defined. Trial is still recruiting.
Time to progressionNo time frame defined. Trial is still recruiting.
Response durationNo time frame defined. Trial is still recruiting.

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026