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1999-08-11
2002-05
N/A
N/A
NCT00003810
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
INTERVENTIONAL
Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Pancreas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more that one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and docetaxel in treating patients who have locally advanced or metastatic cancer of the pancreas.
OBJECTIVES: I. Determine the objective response rate of patients with pancreatic adenocarcinoma treated with combination gemcitabine and docetaxel. II. Determine the toxicity profile of this combination therapy in these patients. III. Assess the survival rate of these patients. OUTLINE: Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes. Patients receive treatment every other week for 8 weeks (4 courses). Patients may continue treatment in the absence of unacceptable toxicity or disease progression. Patients are followed every 12 weeks until death. PROJECTED ACCRUAL: This study will accrue approximately 10 patients per month for a maximum of 33 patients.
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 |
|---|---|---|
1999-11-01 | N/A | 2023-06-13 |
2004-08-03 | N/A | 2023-06-15 |
2004-08-04 | N/A | 2023-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
N/A
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
