Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
First received: July 11, 2001
Last updated: March 23, 2011
Last verified: January 2005

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 Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: epirubicin hydrochloride
Drug: irinotecan hydrochloride
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer

Resource links provided by NLM:

Further study details as provided by Georgetown University:

Study Start Date: August 2000
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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 Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: John Marshall, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00020748     History of Changes
Other Study ID Numbers: CDR0000068710, P30CA051008, GUMC-00191, GUMC-072000-001, NCI-G01-1956
Study First Received: July 11, 2001
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Antibiotics, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 24, 2015