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Sponsors and Collaborators: |
Lombardi Cancer Research Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020748 |
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 I |
MedlinePlus related topics: | Cancer |
ChemIDplus related topics: | Irinotecan Irinotecan hydrochloride Epirubicin hydrochloride Epirubicin |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer |
Study Start Date: | August 2000 |
OBJECTIVES:
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 |
DISEASE CHARACTERISTICS:
Histologically documented incurable malignancy for which there is no beneficial standard therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, District of Columbia | |||||
Lombardi Cancer Center at Georgetown University Medical Center | |||||
Washington, District of Columbia, United States, 20007 |
Lombardi Cancer Research Center |
National Cancer Institute (NCI) |
Study Chair: | John L. Marshall, MD | Lombardi Cancer Research Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068710, GUMC-00191, GUMC-072000-001, NCI-G01-1956 |
First Received: | July 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00020748 |
Health Authority: | United States: Federal Government |
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