Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas
NCT ID: NCT00005870
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
INTERVENTIONAL
1999-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to Karnofsky performance status (50-70% vs greater than 70%). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive oral nitrocamptothecin on days 1-5. Treatment repeats every week for 8 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after week 8 may receive additional courses. Arm II: Patients are stratified according to most appropriate therapy possible (mitomycin or investigator's choice (including best supportive care) vs gemcitabine vs fluorouracil). Patients who previously received fluorouracil and gemcitabine with or without radiotherapy receive mitomycin or the investigator's choice of any proven or experimental chemotherapy regimen previously submitted to the sponsor. Patients who previously received fluorouracil only, other chemotherapy only, or fluorouracil with other chemotherapy receive a proven or experimental regimen comprising gemcitabine. Patients who previously received gemcitabine with other chemotherapy receive a proven or experimental regimen comprising fluorouracil. Patients with stable or responding disease after week 8 may receive additional courses if medically indicated. Patients for whom these drugs are not indicated may receive best supportive care. At the time of disease progression, patients may receive treatment with nitrocamptothecin. Patients are followed every 3 months for 1 year or until death.
PROJECTED ACCRUAL: Approximately 400 patients (200 per arm) will be accrued for this study within 15 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fluorouracil
gemcitabine hydrochloride
mitomycin C
rubitecan
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Astex Pharmaceuticals, Inc.
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lawrence A. Romel, MS
Role: STUDY_CHAIR
Astex Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
SuperGen, Incorporated
San Ramon, California, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SUPERGEN-RFS2000-09
Identifier Type: -
Identifier Source: secondary_id
RPCI-DS-99-11
Identifier Type: -
Identifier Source: secondary_id
CDR0000067906
Identifier Type: -
Identifier Source: org_study_id