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)

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: exatecan mesylate Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study of DX-8951f (Exatecan Mesylate for Injection) in Patients With Renal Dysfunction
Study Start Date : May 2002
Actual Study Completion Date : October 2007

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00045318

Layout table for location information
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
St. Luke's Lutheran Hospital
San Antonio, Texas, United States, 78229
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Carolyn Britten, MD Jonsson Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00045318     History of Changes
Other Study ID Numbers: DAIICHI-8951A-PRT026
CDR0000256866 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: April 2003
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
Layout table for MeSH terms
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic