Irinotecan in Treating Asian Patients With Solid Tumors

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00731276
• Date of registration: 07/08/2008
• Primary sponsor: National Cancer Centre, Singapore
• Public title: Irinotecan in Treating Asian Patients With Solid Tumors
• Scientific title: Phase I Study to Investigate Genotype-Based Dose Individualization in Asian Cancer Patients
• Date of first enrolment: June 2008
• Target sample size: 48
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00731276
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Singapore

Contacts

• Name: Donald Poon, MD

• Name: Balram Chowbay, MD
• Affiliation: National Cancer Centre, Singapore

• Name: Donald Poon, MD
• Affiliation: National Cancer Centre, Singapore

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Unspecified Adult Solid Tumor, Protocol Specific

Intervention(s)

Drug: irinotecan hydrochloride

Other: pharmacogenomic studies

Other: pharmacological study

Primary Outcome(s)

Dose-limiting toxicity [Time Frame: Yes]

Maximum tolerated dose [Time Frame: Yes]

Secondary Outcome(s)

Pharmacokinetics [Time Frame: No]

Response duration [Time Frame: No]

Time to progression [Time Frame: No]

Time to tumor response [Time Frame: No]

Secondary ID(s)

CDR0000601207

SINGAPORE-NCC0703

Source(s) of Monetary Support

Please refer to primary and secondary sponsors