A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With Advanced Cancer
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study of Epirubicin in Combination With Irinotecan in Patients With 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
John L. Marshall, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Lombardi Cancer Research Center
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068710
NCT ID:
NCT00020748
Start Date:
August 2000
Completion Date:
October 2004
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Lombardi Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
