Working… Menu

Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00045318
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE September 6, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 10, 2013
Study Start Date  ICMJE May 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00045318 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
Official Title  ICMJE A Phase I Study of DX-8951f (Exatecan Mesylate for Injection) in Patients With Renal Dysfunction
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction.

Detailed Description


  • Determine the maximum tolerated dose of exatecan mesylate in patients with advanced solid tumors and varying degrees of renal dysfunction.
  • Determine the dose-limiting and non-dose-limiting toxic effects of this drug in these patients.
  • Determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Establish a model for dosing this drug in patients with impaired renal function.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to severity of renal dysfunction (normal vs mild vs moderate vs severe).

Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients in each renal dysfunction stratum receive escalating doses of exatecan mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients in the normal renal function stratum do not undergo dose escalation.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 45 patients (6 normal, 9 mild, 12 moderate, and 18 severe renal dysfunction) will be accrued for this study within 1.5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE Drug: exatecan mesylate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE


  • Histologically or cytologically confirmed advanced solid tumor refractory to standard therapy or for which no standard therapy exists
  • Renal function as defined by the following parameters:

    • Normal (creatinine clearance (CrCl) greater than 80 mL/min)
    • Mild dysfunction (CrCl 50-80 mL/min)
    • Moderate dysfunction (CrCl 30-50 mL/min)
    • Severe dysfunction (CrCl less than 30 mL/min)
    • End-stage renal disease (requiring dialysis)
  • No symptomatic or active brain metastases (e.g., edema or progression on CT scan or MRI)



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin at least 9.0 g/dL


  • Bilirubin normal
  • AST or ALT no greater than 2 times upper limit of normal
  • Albumin at least 2.8 g/dL


  • See Disease Characteristics


  • No active congestive heart failure
  • No uncontrolled angina
  • No myocardial infarction within the past 6 months


  • No concurrent serious infection
  • No other life-threatening illness
  • No overt psychosis or mental disability or other incompetency that would preclude informed consent
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy

  • No concurrent anticancer biologic therapy


  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered
  • No prior exatecan mesylate
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent anticancer hormonal therapy
  • Concurrent megestrol for appetite stimulation allowed


  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent anticancer radiotherapy


  • At least 4 weeks since prior major surgery and recovered
  • No concurrent anticancer surgery


  • At least 4 weeks since prior investigational drugs including analgesics or antiemetics
  • At least 1 week since prior grapefruit juice
  • No other concurrent anticancer therapy
  • No other investigational drugs during and for 4 weeks after study
  • No concurrent grapefruit juice
  • No other concurrent anticancer cytotoxic therapy
  • Concurrent chronic hemodialysis or ambulatory peritoneal dialysis allowed
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00045318
Other Study ID Numbers  ICMJE DAIICHI-8951A-PRT026
CDR0000256866 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Carolyn Britten, MD Jonsson Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP