Irinotecan in Treating Asian Patients With Solid Tumors

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731276
• Other study ID #: CDR0000601207
• Secondary ID: SINGAPORE-NCC070
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2008
• Last updated: March 29, 2017
• Start date: April 3, 2008
• Est. completion date: April 2016

Study information

• Verified date: March 2017
• Source: National Cancer Centre, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• irinotecan hydrochloride

Other:
• pharmacogenomic studies

• pharmacological study

Locations

Country	Name	City	State
Singapore	National Cancer Centre - Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity		No time frame defined. Trial is still recruiting.
Primary	Maximum tolerated dose		No time frame defined. Trial is still recruiting.
Secondary	Pharmacokinetics		No time frame defined. Trial is still recruiting.
Secondary	Time to tumor response		No time frame defined. Trial is still recruiting.
Secondary	Time to progression		No time frame defined. Trial is still recruiting.
Secondary	Response duration		No time frame defined. Trial is still recruiting.