Overview

Epirubicin Plus Irinotecan in Treating Patients With Advanced Cancer

Status:
Completed
Trial end date:
2004-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Georgetown University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Epirubicin
Irinotecan
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