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

Phase 1
21 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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



- To determine the dose-limiting toxicity and maximum tolerated dose of irinotecan
hydrochloride according to the genotype status of Asian patients with solid tumors.


- 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

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

Patients undergo blood sample collection periodically for pharmacogenetic, pharmacokinetic,
and pharmacodynamic studies.

Inclusion Criteria


- 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


- 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


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Outcome Time Frame:

No time frame defined. Trial is still recruiting.

Safety Issue:


Principal Investigator

Su Pin Choo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Centre, Singapore


Singapore: Health Sciences Authority

Study ID:




Start Date:

June 2008

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms