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Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00020748
First Posted: January 27, 2003
Last Update Posted: March 24, 2011
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Georgetown University
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

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
Criteria

DISEASE CHARACTERISTICS:

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

    • Locally unresectable or metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks

Hematopoietic:

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

Hepatic:

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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • Recovered from prior therapy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00020748


Locations
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)
Investigators
Study Chair: John L. Marshall, MD Lombardi Comprehensive Cancer Center
  More Information

Responsible Party: John Marshall, MD, Georgetown University
ClinicalTrials.gov Identifier: NCT00020748     History of Changes
Other Study ID Numbers: CDR0000068710
P30CA051008 ( U.S. NIH Grant/Contract )
GUMC-00191
GUMC-072000-001
NCI-G01-1956
First Submitted: July 11, 2001
First Posted: January 27, 2003
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:
Irinotecan
Camptothecin
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors