Overview

Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Solid Tumors

Status:
Completed
Trial end date:
2009-12-01
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 combination chemotherapy in treating patients who have locally advanced or metastatic solid tumors.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cisplatin
Fluorouracil
Irinotecan
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed solid tumor malignancy not amenable to
curative surgery or chemoradiation No CNS metastases, carcinomatous meningitis, or
interstitial pulmonary fibrosis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL
AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases)
No known Gilbert's disease Renal: Creatinine no greater than 1.5 mg/dL Calcium less than
12.0 mg/dL No symptomatic hypercalcemia Cardiovascular: No unstable angina No New York
Heart Association class III or IV cardiac disease Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No active or uncontrolled
infection No history of seizure disorder No uncontrolled diabetes mellitus, defined as
random blood sugar 250 mg/dL or greater

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and
recovered No prior mantle irradiation, hemibody irradiation, or radiation to the pelvis or
lumbar spine Surgery: See Disease Characteristics Other: No concurrent phenytoin,
phenobarbital, or other antiepileptic medication No concurrent prochlorperazine on day of
irinotecan administration No concurrent prophylactic loperamide