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	Treatment or Intervention	Phase
recurrent pancreatic cancer stage IVA pancreatic cancer stage III pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: cisplatin  Drug: docetaxel  Drug: gemcitabine	Phase II

Further Study 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.

Ages Eligible for Study:  18 Years and above

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

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

Study chairs or principal investigators

Manfred Lutz,  Study Chair,  EORTC Gastrointestinal Tract Cancer Cooperative Group   

Study ID Numbers:  CDR0000067559; EORTC-40984
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004884
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08