Irinotecan in Treating Asian Patients With Solid Tumors

NCT ID: NCT00731276

Last Updated: 2017-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-03
• Study Completion Date: 2016-04-30

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Four Regimens

The study has four type of regimens, and dosing of irinotecan depends on genotype of patient.

Four Regimens are:

1. Weekly Irinotecan (Irinotecan given at day 1, 8 and 15) every four weekly

2. Weekly Xeliri ( Irinotecan given at day 1, 8 and 15)+ (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly

3. Three-weekly Xeliri (Irinotecan given at day 1 only) + (Xeloda tabs 2000mg/m2 consumed over 14 days) every three weekly

4. Two-weekly FOLFIRI (Irinotecan given at day 1 only) + (CI Fluorouracil 600mg/m2 over 22hrs, IV Folinic Acid 200mg/m2 over 2hrs and IVP Fluorouracil 400mg/m2) every two weekly

Group Type: OTHER

irinotecan hydrochloride

Intervention Type: DRUG

pharmacogenomic studies

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Interventions

irinotecan hydrochloride

Intervention Type: DRUG

pharmacogenomic studies

Intervention Type: OTHER

pharmacological study

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Su Pin Choo, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre - Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

SINGAPORE-NCC0703

Identifier Type: -

Identifier Source: secondary_id

CDR0000601207

Identifier Type: -

Identifier Source: org_study_id