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| 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 |
| 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 |
| Study Start Date: | July 1999 |
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 |
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| 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 | |||||
| European Organization for Research and Treatment of Cancer |
| 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 
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Lutz MP, Van Cutsem E, Wagener T, Van Laethem JL, Vanhoefer U, Wils JA, Gamelin E, Koehne CH, Arnaud JP, Mitry E, Husseini F, Reichardt P, El-Serafi M, Etienne PL, Lingenfelser T, Praet M, Genicot B, Debois M, Nordlinger B, Ducreux MP; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group. J Clin Oncol. 2005 Dec 20;23(36):9250-6.
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Lutz MP, Ducreux M, Wagener T, et al.: Docetaxel/gemcitabine or docetaxel/cisplatin in advanced pancreatic carcinoma: a randomized phase II study of the EORTC-GI group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-498, 2002.
  |
| 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 |
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