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- Klinische proef NCT00731276
Irinotecan in Treating Asian Patients With Solid Tumors
Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Singapore, Singapore, 169610
- National Cancer Centre - Singapore
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Ander: Four Regimens
The study has four type of regimens, and dosing of irinotecan depends on genotype of patient. Four Regimens are:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Dose-limiting toxicity
Tijdsspanne: No time frame defined. Trial is still recruiting.
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No time frame defined. Trial is still recruiting.
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Maximum tolerated dose
Tijdsspanne: No time frame defined. Trial is still recruiting.
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No time frame defined. Trial is still recruiting.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Pharmacokinetics
Tijdsspanne: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
|
Time to tumor response
Tijdsspanne: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
|
Time to progression
Tijdsspanne: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
|
Response duration
Tijdsspanne: No time frame defined. Trial is still recruiting.
|
No time frame defined. Trial is still recruiting.
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Su Pin Choo, MD, National Cancer Centre, Singapore
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CDR0000601207
- SINGAPORE-NCC0703
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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