Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

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: NCT00020748
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 24, 2011
National Cancer Institute (NCI)
Information provided by:
Georgetown University

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating patients who have advanced cancer.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: epirubicin hydrochloride Drug: irinotecan hydrochloride Phase 1

Detailed Description:


  • Determine the dose-limiting toxicity and maximum tolerated dose of epirubicin and irinotecan in patients with advanced cancer.
  • Determine the objective antitumor responses in patients treated with this regimen.
  • Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive irinotecan IV over 1 hour followed by epirubicin IV over 5 minutes on days 1 and 8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Sequential dose escalation of epirubicin is followed by sequential dose escalation of irinotecan. Cohorts of 3-6 patients receive escalating doses of epirubicin and irinotecan until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer
Study Start Date : August 2000
Primary Completion Date : October 2004
Study Completion Date : October 2004

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically documented incurable malignancy for which there is no beneficial standard therapy

    • Locally unresectable or metastatic disease



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks


  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.2 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2 times ULN


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • Ejection fraction at least 50% by MUGA scan
  • No congestive heart failure


  • Maintaining a reasonable state of nutrition
  • No frequent vomiting or severe anorexia
  • No weight loss greater than 10% of current body weight within the past 4 weeks
  • No other concurrent medical illness that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • No concurrent immunotherapy


  • Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2

Endocrine therapy:

  • Not specified


  • No concurrent radiotherapy


  • Not specified


  • Recovered from prior therapy

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): NCT00020748

United States, District of Columbia
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
National Cancer Institute (NCI)
Study Chair: John L. Marshall, MD Lombardi Comprehensive Cancer Center

Responsible Party: John Marshall, MD, Georgetown University Identifier: NCT00020748     History of Changes
Other Study ID Numbers: CDR0000068710
P30CA051008 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: January 2005

Keywords provided by Georgetown University:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors