NCT00808184

Brief Summary

The objectives of this study are: To correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38. To correlate the genotype of UGT1A1 of patients receiving CPT-11 chemotherapy with irinotecan and raltegravir pharmacokinetic parameters. To model pharmacokinetic and pharmacodynamic behaviour of CPT-11 in the study population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 15, 2008

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 1, 2012

Status Verified

April 1, 2010

Enrollment Period

1.8 years

First QC Date

December 11, 2008

Last Update Submit

October 31, 2012

Conditions

Solid Tumor

Keywords

Histologically or cytologically proven solid tumour for which CPT-11 given by the Folfiri regimen

Outcome Measures

Primary Outcomes (1)

  • Correlate pharmacokinetic parameters of raltegravir and midazolam with irinotecan (CPT-11) and its metabolite SN-38

    1 year

Study Arms (1)

CPT-11

ACTIVE COMPARATOR
Drug: CPT-11, Raltegravir (Isentress®), Midazolam

Interventions

CPT-11, Raltegravir (Isentress®), MidazolamDRUG
CPT-11

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically proven solid tumour for which CPT-11 given by the Folfiri regimen is indicated and prescribed by the attending physician.
  • Age above 21 years.
  • Measurable or evaluable disease
  • Karnofsky performance status \> 70%
  • Life expectancy \> 3 months
  • WBC \> 3.0 x 103/?l; ANC \> 1500/?l
  • Hemoglobin \> 9.0 g/dl
  • Platelets \> 100000/?l
  • Creatinine \< 1.5 x ULN or calculated creatinine clearance \> 40 ml/min
  • Total bilirubin \< 1.5 x ULN
  • SGOT, SGPT \< 5 x ULN unless due to disease

You may not qualify if:

  • Biologic therapy or chemotherapy within 4 weeks. (Six weeks for prior nitrosoureas or mitomycin C).
  • Radiation therapy within 4 weeks if \> 25% of bone marrow was irradiated.
  • Have not received any medications that are known to be metabolised by UGT1A1 within 30 days of the first dose of CPT-11.
  • Short gut syndrome or other causes of malabsorption.
  • Colony stimulating factors within 2 weeks.
  • Women of childbearing potential not practicing birth control. (Note: by means other than oral contraception)
  • Pregnant women
  • Severe peripheral neuropathy grade 2 or higher.
  • Medical or psychiatric conditions which may impair the patient's ability to provide informed consent.
  • Hypersensitivity to CPT-11, raltegravir or midazolam/other benzodiazepines.
  • Rapidly progressive intracranial or spinal metastatic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (3)

  • Atsumi R, Suzuki W, Hakusui H. Identification of the metabolites of irinotecan, a new derivative of camptothecin, in rat bile and its biliary excretion. Xenobiotica. 1991 Sep;21(9):1159-69. doi: 10.3109/00498259109039556.

    PMID: 1788984BACKGROUND

  • Gupta E, Mick R, Ramirez J, Wang X, Lestingi TM, Vokes EE, Ratain MJ. Pharmacokinetic and pharmacodynamic evaluation of the topoisomerase inhibitor irinotecan in cancer patients. J Clin Oncol. 1997 Apr;15(4):1502-10. doi: 10.1200/JCO.1997.15.4.1502.

    PMID: 9193346BACKGROUND

  • Lee LS, Seng KY, Wang LZ, Yong WP, Hee KH, Soh TI, Wong A, Cheong PF, Soong R, Sapari NS, Soo R, Fan L, Lee SC, Goh BC. Phenotyping of UGT1A1 Activity Using Raltegravir Predicts Pharmacokinetics and Toxicity of Irinotecan in FOLFIRI. PLoS One. 2016 Jan 25;11(1):e0147681. doi: 10.1371/journal.pone.0147681. eCollection 2016.

    PMID: 26808671DERIVED

MeSH Terms

Interventions

IrinotecanRaltegravir PotassiumMidazolam

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Boon Cher Goh, MRCP

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 15, 2008

Study Start

April 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 1, 2012

Record last verified: 2010-04

Locations

SG(2)