Irinotecan in Treating Asian Patients With Solid Tumors

This study is currently recruiting participants.
Verified June 2013 by National Cancer Centre, Singapore
Sponsor:
Information provided by (Responsible Party):
Choo Su Pin, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier:
NCT00731276
First received: August 7, 2008
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: irinotecan hydrochloride
Other: pharmacogenomic studies
Other: pharmacological study
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study to Investigate Genotype-based Dose Individualization of Irinotecan in Asian Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Centre, Singapore:

Primary Outcome Measures:
  • Dose-limiting toxicity [ Time Frame: No time frame defined. Trial is still recruiting. ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Time Frame: No time frame defined. Trial is still recruiting. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: No time frame defined. Trial is still recruiting. ] [ Designated as safety issue: No ]
  • Time to tumor response [ Time Frame: No time frame defined. Trial is still recruiting. ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: No time frame defined. Trial is still recruiting. ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: No time frame defined. Trial is still recruiting. ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: June 2008
Arms Assigned Interventions
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
Drug: irinotecan hydrochloride Other: pharmacogenomic studies Other: pharmacological study

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731276

Locations
Singapore
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169610
Contact: Su Pin Choo, MD    65-6-436-8000      
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
Principal Investigator: Su Pin Choo, MD National Cancer Centre, Singapore
  More Information

Additional Information:
No publications provided

Responsible Party: Choo Su Pin, Senior Consultant, National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT00731276     History of Changes
Other Study ID Numbers: CDR0000601207, SINGAPORE-NCC0703
Study First Received: August 7, 2008
Last Updated: June 14, 2013
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National Cancer Centre, Singapore:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014