Overview

Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas

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 other chemotherapy for cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with that of other chemotherapy in treating patients who have recurrent or refractory cancer of the pancreas.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Astex Pharmaceuticals
Astex Pharmaceuticals, Inc.
Treatments:
Fluorouracil
Gemcitabine
Mitomycin
Mitomycins
Rubitecan
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven adenocarcinoma of the
pancreas with failure or relapse after at least 1 prior chemotherapy regimen Ineligible if
only prior chemotherapy regimen consisted of gemcitabine alone or fluorouracil as a
radiosensitizer No prior nitrocamptothecin or other camptothecin analogs

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 50-100% Life
expectancy: At least 8 weeks Hematopoietic: Granulocyte count greater than 1,500/mm3
Hemoglobin greater than 9 g/dL Platelet count greater than 100,000/mm3 Hepatic: SGOT and
SGPT no greater than 3 times normal (5 times normal if liver tumor present) 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: At least 2 weeks since prior immunotherapy and
recovered No concurrent filgrastim (G-CSF) with nitrocamptothecin No concurrent anticancer
immunotherapy Chemotherapy: See Disease Characteristics At least 2 weeks since prior
chemotherapy and recovered No other concurrent anticancer chemotherapy Endocrine therapy:
No concurrent anticancer hormonal therapy Radiotherapy: At least 2 weeks since prior
radiotherapy and recovered No concurrent anticancer radiotherapy Surgery: At least 2 weeks
since prior surgery and recovered No planned major surgery within 8 weeks after initiation
of treatment