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2004-09
N/A
N/A
80
NCT00268411
National Cancer Institute (NCI)
National Cancer Institute (NCI)
INTERVENTIONAL
Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days. PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.
OBJECTIVES: Primary * Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin. Secondary * Compare the clinical benefits and tolerability of these regimens in these patients. * Compare the progression-free and overall survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. * Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1. In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
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 |
|---|---|---|
2005-12-20 | N/A | 2008-05-23 |
2005-12-20 | N/A | 2008-05-27 |
2005-12-22 | N/A | 2007-05 |
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 |
|---|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective response rate |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Clinical benefits and tolerability | ||
| Progression-free and overall survival |
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
