Overview

Irofulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer

Status:
Completed
Trial end date:
2000-05-01
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. PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborators:
Merck Sharp & Dohme Corp.
National Cancer Institute (NCI)
University of Texas
Treatments:
Irofulven
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage III or IV
unresectable adenocarcinoma of the exocrine pancreas Must have been treated with 1 prior
gemcitabine regimen, and have documented disease progression either during or within 6
months after completion of therapy Measurable or evaluable disease outside of previously
irradiated area No islet cell tumors or lymphoma of the pancreas No significant CNS disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL
Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 2 times upper limit
of normal (ULN) (no greater than 5 times ULN if liver metastases) Renal: Creatinine no
greater than 1.5 mg/dL Cardiovascular: No atrial or ventricular arrhythmias requiring
medication No atrial fibrillation (with or without medication) No ischemic event within
past 6 months No history of congestive heart failure Other: Not pregnant or nursing Fertile
patients must use effective contraception No significant psychiatric disorders No active
infection No other prior malignancies within past 5 years, except: Basal or squamous cell
skin cancer Carcinoma in situ of the cervix No concurrent serious systemic disorder

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy No concurrent
immunotherapy Chemotherapy: At least 4 weeks since prior gemcitabine therapy and recovered
No other prior chemotherapy (except fluorouracil as a radiation enhancing agent) No other
concurrent chemotherapy Endocrine therapy: No prior hormonal therapy No concurrent hormonal
therapy (except contraceptives, hormone replacement, or megestrol acetate) Radiotherapy: At
least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery:
Not specified Other: At least 4 weeks since prior investigational agents