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Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004884
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: cisplatin
Drug: docetaxel
Drug: gemcitabine hydrochloride
Phase II

MedlinePlus related topics:   Cancer    Pancreatic Cancer   

Drug Information available for:   Docetaxel    Cisplatin    Gemcitabine hydrochloride    Gemcitabine    Pancrelipase    Ultrase   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1999

Detailed Description:

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.

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004884

Locations
Belgium
Hopital Universitaire Erasme    
      Brussels, Belgium, 1070
Institut Jules Bordet    
      Brussels, Belgium, 1000
U.Z. Gasthuisberg    
      Leuven, Belgium, B-3000
Egypt
National Cancer Institute of Egypt    
      Cairo, Egypt
France
Centre Alexis Vautrin    
      Vandoeuvre-les-Nancy, France, 54511
CHU Ambroise Pare    
      Boulogne Billancourt, France, F-92104
Institut Gustave Roussy    
      Villejuif, France, F-94805
Germany
Hermann-Holthusen Institute for Radiotherapy    
      Hamburg, Germany, D-20099
Klinikum der J.W. Goethe Universitaet    
      Frankfurt, Germany, D-60590
Klinikum der Universitaet Ulm    
      Ulm, Germany, D-89081
Klinikum St. Marien    
      Amberg, Germany, D-92224
Marien Hospital    
      Hagen, Germany, 58095
Medizinische Hochschule Hannover    
      Hannover, Germany, D-30625
Praxis Innere Medizin    
      Neustadt, Germany, D-01844
Universitaetsklinik und Strahlenklinik - Essen    
      Essen, Germany, D-45122
Netherlands
Saint Laurentius Ziekenhuis    
      Roermond, Netherlands, 6043 CV
Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology    
      Warsaw, Poland, 02-781
Turkey
Dokuz Eylul University School of Medicine    
      Izmir, Turkey, 35340
United Kingdom, Scotland
Beatson Oncology Centre    
      Glasgow, Scotland, United Kingdom, G11 6NT

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair:     Manfred Lutz, MD     Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000067559, EORTC-40984
First Received:   March 7, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00004884
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer  
recurrent pancreatic cancer  
adenocarcinoma of the pancreas  
stage IV pancreatic cancer  

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Recurrence
Carcinoma
Docetaxel
Digestive System Diseases
Cisplatin
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on December 03, 2008




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