Clinical trial · Interventional
Irinotecan in Treating Asian Patients With Solid Tumors
Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
NCT00731276CI-TRIAL-00026734completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| pharmacogenomic studies | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Four Regimens
- description
- 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
- interventionNames
- Drug: irinotecan hydrochloride
- Other: pharmacogenomic studies
- Other: pharmacological study
Primary outcomes (2)
- measure
- Dose-limiting toxicity
- timeFrame
- No time frame defined. Trial is still recruiting.
- measure
- Maximum tolerated dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.