Overview

Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer

Status:
Unknown status
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. It is not yet known whether nitrocamptothecin is more effective than fluorouracil for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of fluorouracil in treating patients who have recurrent or refractory pancreatic cancer and who have been treated previously with gemcitabine.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Treatments:
Fluorouracil
Rubitecan
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent or refractory
adenocarcinoma of the pancreas Must have received prior gemcitabine and progressed

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life
expectancy: At least 2 months Hematopoietic: Granulocyte count greater than 1,500/mm3
Hemoglobin at least 9 g/dL Platelet count greater than 100,000/mm3 Hepatic: SGOT and SGPT
no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if tumor
involves liver) Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0
mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See
Disease Characteristics At least 2 weeks since prior gemcitabine and recovered No prior
chemotherapy except gemcitabine No other concurrent chemotherapy Endocrine therapy: No
concurrent corticosteroids or hormones Radiotherapy: No concurrent radiotherapy Surgery: At
least 2 weeks since prior major surgery No major surgery within 8 weeks following
initiation of study treatment