Expired Study
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Washington, District of Columbia 20007


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.


Study summary:

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.


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


NCT ID:

NCT00020748


Primary Contact:

Study Chair
John L. Marshall, MD
Lombardi Cancer Research Center


Backup Contact:

N/A


Location Contact:

Washington, District of Columbia 20007
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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