Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

Georgetown University

Status and phase: Completed; Phase 1

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: epirubicin hydrochloride; Drug: irinotecan hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00020748

GUMC-072000-001

P30CA051008 (U.S. NIH Grant/Contract)

NCI-G01-1956

CDR0000068710

GUMC-00191

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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