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1998-11
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NCT00005869
National Cancer Institute (NCI)
National Cancer Institute (NCI)
INTERVENTIONAL
Nitrocamptothecin Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer
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 gemcitabine for pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of nitrocamptothecin with gemcitabine in treating patients who have unresectable locally advanced or metastatic pancreatic cancer.
OBJECTIVES: I. Compare the overall survival, time to treatment failure, clinical benefit response rate (analgesic consumption, pain intensity, performance status, and weight change), and objective response rate in chemotherapy-naive patients with unresectable locally advanced or metastatic adenocarcinoma of the pancreas treated with oral nitrocamptothecin vs gemcitabine. II. Compare the toxicity of these 2 regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to measurable disease (yes vs no), Karnofsky performance status (50-70% vs 70-100%), and prior radiotherapy. 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 receive gemcitabine IV over 30 minutes on day 1. Treatment repeats every week for 7 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo 1 week of rest. Patients with stable or responding disease after week 8 may receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Courses repeat every 4 weeks. Pain is assessed within 7 days prior to study, at days 28 and 56 during study, and then every 28 days after completion of study. Patients are followed every 3 months for 1 year or until death. PROJECTED ACCRUAL: Approximately 994 patients (497 per arm) will be accrued for this study within 22 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2000-06-02 | N/A | 2013-12-03 |
2004-02-24 | N/A | 2013-12-04 |
2004-02-25 | N/A | 2007-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
