Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Georgetown University
ClinicalTrials.gov Identifier:
NCT00020748
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 ClinicalTrials.gov 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.

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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2004
October 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020748
CDR0000068710, P30CA051008, GUMC-00191, GUMC-072000-001, NCI-G01-1956
No
John Marshall, MD, Georgetown University
Georgetown University
National Cancer Institute (NCI)
Study Chair: John L. Marshall, MD Lombardi Cancer Research Center
Georgetown University
January 2005

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