|
Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer Clinical research trials and Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer. Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer  Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,stage 4B pancreatic cancer,recurrent pancreatic cancer,stage 4A pancreatic cancer,adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): EORTC Gastrointestinal Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.
Details: OBJECTIVES: I. Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin in patients with metastatic or locoregionally advanced pancreatic cancer. II. Assess the toxicity, response rate, duration of response, time to progression, survival, performance status, and weight associated with these treatment regimens in these patients. PROTOCOL OUTLINE: This is a randomized, open label, multicenter study. Patents are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Arm II: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression, and then every 8 weeks until death. PROJECTED ACCRUAL: Up to 82 patients (41 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed metastatic or locoregionally advanced (with metastatic lymph nodes) unresectable adenocarcinoma of the exocrine pancreas - Bidimensionally measurable disease outside previously irradiated fields - No CNS involvement or leptomeningeal disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Concurrent radiotherapy allowed if indicator lesions not included in irradiated field; See Disease Characteristics - Surgery: Not specified - Other: No concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin less than 1.5 times the upper limit of normal (ULN) - Renal: Creatinine no greater than ULN - Other: No prior second malignancy in the past 10 years except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin; No psychological, familial, sociological, or geographical condition that precludes study compliance Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ManfredLutz, Study Chair, EORTC Gastrointestinal Tract Cancer Cooperative Group
Saint Laurentius Ziekenhuis
Roermond, , 6043 CV
Netherlands
Dokuz Eylul University School of Medicine
Izmir, , 35340
Turkey
Klinikum der Universitaet Ulm
Ulm, , D-89081
Germany
Praxis Innere Medizin
Neustadt, , D-01844
Germany
Universitaetsklinik und Strahlenklinik - Essen
ESSEN, , D-45122
Germany
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Medizinische Hochschule Hannover
Hannover, , D-30625
Germany
Institut Gustave Roussy
Villejuif, , F-94805
France
Hermann-Holthusen Institute for Radiotherapy
Hamburg, , D-20099
Germany
Beatson Oncology Centre
Glasgow, Scotland, G11 6NT
United Kingdom
Klinikum St. Marien
Amberg, , D-92224
Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , D-60590
Germany
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
CHU Ambroise Pare
Boulogne-Billancourt, , F-92104
France
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Institut Jules Bordet
Brussels, , 1000
Belgium
National Cancer Institute of Egypt
Cairo, ,
Egypt
Marien Hospital
Hagen, , 58095
Germany
Additional Information:
Study ID Numbers: CDR0000067559; EORTC-40984
Study Start Date: July 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004884
Other Stage 4b Pancreatic Cancer Studies:
1. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
2. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
3. Arsenic Trioxide in Treating Patients With Pancreatic Cancer That Has Not Responded to Gemcitabine
4. Gemcitabine Plus Oxaliplatin in Treating Patients With Refractory Locally Advanced or Metastatic Pancreatic Cancer
5. Antineoplaston Therapy in Treating Patients With Stage IV Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other Clinical Trials
Other Hagen Clinical Trials
Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
|
|
|
|
|
|
|
|
