Overview

Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer

Status:
Completed
Trial end date:
2002-04-01
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 oxaliplatin plus irinotecan in treating patients with previously treated metastatic gastrointestinal cancer that has not responded to previous treatment.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Irinotecan
Oxaliplatin
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic gastrointestinal carcinoma
Measurable disease No CNS metastases No obstruction or partial obstruction of GI tract No
obstruction of genitourinary tract

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least
1,500/mm3 Platelet count at least 125,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal:
Creatinine no greater than 1.5 mg/dL Cardiovascular: No uncontrolled high blood pressure,
unstable angina, active congestive heart failure, myocardial infarction within prior 6
months, or serious uncontrolled cardiac arrhythmia Neurological: No concurrent symptomatic
peripheral sensory neuropathy Other: No active or uncontrolled infection Not pregnant or
nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cisplatin,
oxaliplatin, nitrosoureas, or mitomycin C 1 or 2 prior chemotherapy regimens allowed
(including irinotecan) Endocrine therapy: Not specified Radiotherapy: No prior radiation
therapy to whole pelvis, 30% or greater of bone marrow, and site of measurable disease At
least 4 weeks since prior radiation therapy and recovered Surgery: Not specified