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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. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors

2. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

3. Nitrocamptothecin Compared With Other Chemotherapy in Treating Patients With Recurrent or Refractory Cancer of the Pancreas

4. Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer

5. Combination Chemotherapy in Treating Patients With Stage III or Stage IV Pancreatic Cancer That Cannot Be Removed by Surgery

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