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Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas Clinical research trials and Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas  Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
For Condition: stage 4A pancreatic cancer,stage 4B pancreatic cancer,stage 3 pancreatic cancer,adenocarcinoma of the pancreas
Status: No longer recruiting
Sponsor(s): EORTC Chronotherapy Study 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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether fluorouracil plus cisplatin are more effective than fluorouracil alone in treating patients with metastatic cancer of the pancreas. PURPOSE: Randomized phase III trial to compare the effectiveness of fluorouracil with or without cisplatin in treating patients who have advanced or metastatic cancer of the pancreas.
Details: OBJECTIVES: - Confirm the value of chronomodulated infusion with respect to survival in patients with locally advanced or metastatic pancreatic cancer. - Test the value of adding cisplatin to fluorouracil in extending survival in these patients. OUTLINE: This is a multicenter, randomized study. The study design is a 2 X 2 factorial such that patients are allocated to one of 4 treatment groups involving the use or absence of chronomodulation and cisplatin (CDDP). Treatment in each of the 4 groups is repeated for 3 courses where each course is a 5-day course of treatment. Patients in the first group receive a chronomodulated schedule based on delivery of fluorouracil (FU). Patients in the second group receive a chronomodulated schedule of FU and CDDP. Patients in the third and fourth experimental groups receive flat schedules of FU alone or FU and CDDP, respectively. Dosages of FU are increased across the three courses whereas dosages of CDDP remain constant. Treatment is continued until disease progression, severe toxicity, or complete remission for more than 4 months occurs. PROJECTED ACCRUAL: 200 patients will be accrued.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologic or cytologic proof of adenocarcinoma of the exocrine pancreas or of a metastasis associated with a radiologically identified pancreatic tumor - Locally advanced and/or metastatic pancreatic cancer - No measurable or evaluable target lesion is required - No brain metastasis PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 40%-100% Hematopoietic: - WBC at least 3,000/mm^3 - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 3 times normal Renal: - Creatinine no greater than 1.24 mg/dL OR - Creatinine clearance at least 80 mL/min Cardiovascular: - No overt cardiac disease Other: - No peripheral neuropathy - No uncontrolled infectious or chronic disease - No second primary except in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent immunologic therapy Chemotherapy: - No prior chemotherapy allowed Endocrine therapy: - No concurrent hormonal therapy - At least 2 weeks since corticoid treatment Radiotherapy: - No prior radiotherapy allowed except as an analgesic treatment on metastasis Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancisLevi, , Hopital Paul Brousse
Hopital Perpetuel Secours
Levallois-Perret, , 92300
France
Centre Hospitalier de la Cote Basque
Bayonne, , 64109
France
Clinique de l'Orangerie
Strasbourg, , 67010
France
Centre Rene Huguenin
Saint Cloud, , 92211
France
Centre Hospital Regional Universitaire de Limoges
Limoges, , 87042
France
Clinique Hartmann
Neuilly-sur-Seine, , 92200
France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , 21079
France
Les Cliniques Saint-Joseph ASBL
LIEGE, , B 4000
Belgium
Hopital Paul Brousse
Villejuif, , 94804
France
Hopital Bellevue
Saint-Etienne, , 42055
France
Universita G.D'Annunzio Di Chieti
Chieti, , 66100
Italy
Hopital de Jolimont
Haine-Saint-Paul, , 7100
Belgium
Hopital Cochin
Paris, , 75674
France
Hopital Notre-Dame de Bon Secours
Metz, , 55038
France
Wolfson Medical Center
Holon, , 58100
Israel
Hopital Saint-Louis
Paris, , 75475
France
Hospital Fernando Fonseca
Amadora, , P-2700
Portugal
Centre Hospitalier de Montlucon
Montlucon, , 03109
France
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Additional Information:
Study ID Numbers: CDR0000065623; EORTC-05962
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003029
Other Stage 4b Pancreatic Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery
2. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
3. Fluorouracil, Gemcitabine, and Radiation Therapy in Treating Patients With Cancer of the Pancreas
4. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
5. Erlotinib, Gemcitabine, and Radiation Therapy in Treating Patients With Locally Advanced Unresectable Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other Clinical Trials
Other Saint-Etienne Clinical Trials
Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
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