District of Columbia
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.
- 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
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.
- Histologically documented incurable malignancy for which there is no beneficial
- Locally unresectable or metastatic disease
- 18 and over
- ECOG 0-2
- At least 8 weeks
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin no greater than 1.2 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 2 times ULN
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
- Ejection fraction at least 50% by MUGA scan
- No congestive heart failure
- 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:
- No concurrent immunotherapy
- Prior doxorubicin allowed if cumulative dose no greater than 240 mg/m2
- Not specified
- No concurrent radiotherapy
- Not specified
- Recovered from prior therapy