Irinotecan in Treating Asian Patients With Solid Tumors

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Treatments: Camptothecin; Irinotecan

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