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
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
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:
Epirubicin
Irinotecan
Camptothecin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 23, 2014