Overview

Oxaliplatin in Treating Patients With Advanced Cancer Plus Liver Dysfunction

Status:
Completed
Trial end date:
1969-12-31
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. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating patients who have advanced cancer plus liver dysfunction.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
City of Hope Medical Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Oxaliplatin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable malignancy for
which no curative or palliative treatment exists No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 2 months Hematopoietic: Platelet count at least 100,000/mm3 WBC at
least 3,000/mm3 OR Absolute neutrophil count at least 1,500/mm3 Hepatic: Abnormal liver
function allowed Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min
Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No
cardiac arrhythmia Other: No clinically significant neuropathy Not pregnant or nursing
Fertile patients must use effective contraception No history of allergy to platinum
compounds or antiemetics which may be used with study No uncontrolled concurrent illness
(e.g., ongoing or active infection)

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors during
first course of study Chemotherapy: No more than 3 prior regimens of chemotherapy At least
6 weeks since prior platinum chemotherapy At least 4 weeks since other prior chemotherapy
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to more than 30% of
bone marrow Surgery: At least 10 days since placement of biliary shunt Other: No other
concurrent investigational agents No concurrent antiretroviral therapy (HAART) in HIV
positive patients