Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer
NCT ID: NCT00020748
Last Updated: 2011-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2000-08-31
2004-10-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of epirubicin plus irinotecan in treating patients who have advanced cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
Interventions
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epirubicin hydrochloride
irinotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Georgetown University
OTHER
Responsible Party
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Georgetown University
Principal Investigators
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John L. Marshall, MD
Role: STUDY_CHAIR
Lombardi Comprehensive Cancer Center
Locations
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Lombardi Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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GUMC-00191
Identifier Type: -
Identifier Source: secondary_id
GUMC-072000-001
Identifier Type: -
Identifier Source: secondary_id
NCI-G01-1956
Identifier Type: -
Identifier Source: secondary_id
CDR0000068710
Identifier Type: -
Identifier Source: org_study_id
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