Irinotecan in Treating Asian Patients With Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014