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Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

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

July 11, 2001
March 23, 2011
August 2000
October 2004   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00020748 on Archive Site
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Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: epirubicin hydrochloride
  • Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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October 2004
October 2004   (final data collection date for primary outcome measure)


  • 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
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000068710, P30CA051008, GUMC-00191, GUMC-072000-001, NCI-G01-1956
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John Marshall, MD, Georgetown University
Georgetown University
National Cancer Institute (NCI)
Study Chair: John L. Marshall, MD Lombardi Comprehensive Cancer Center
Georgetown University
January 2005

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