Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma |
| Enrollment: | 96 |
| Study Start Date: | July 1999 |
| Primary Completion Date: | March 2001 (Final data collection date for primary outcome measure) |
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 | |
| CHU Ambroise Pare | |
| Boulogne Billancourt, France, F-92104 | |
| Centre Alexis Vautrin | |
| Vandoeuvre-les-Nancy, France, 54511 | |
| Institut Gustave Roussy | |
| Villejuif, France, F-94805 | |
| Germany | |
| Klinikum St. Marien | |
| Amberg, Germany, D-92224 | |
| Universitaetsklinik und Strahlenklinik - Essen | |
| Essen, Germany, D-45122 | |
| Klinikum der J.W. Goethe Universitaet | |
| Frankfurt, Germany, D-60590 | |
| Marien Hospital | |
| Hagen, Germany, 58095 | |
| Hermann-Holthusen Institute for Radiotherapy | |
| Hamburg, Germany, D-20099 | |
| Medizinische Hochschule Hannover | |
| Hannover, Germany, D-30625 | |
| Praxis Innere Medizin | |
| Neustadt, Germany, D-01844 | |
| Klinikum der Universitaet Ulm | |
| Ulm, Germany, D-89081 | |
| 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 | |
| Beatson Oncology Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Study Chair: | Manfred Lutz, MD | Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm |
More Information
Additional Information:
Publications:
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00004884 History of Changes |
| Other Study ID Numbers: | EORTC-40984, EORTC-40984 |
| Study First Received: | March 7, 2000 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage III pancreatic cancer recurrent pancreatic cancer adenocarcinoma of the pancreas stage IV pancreatic cancer |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Docetaxel Cisplatin Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 17, 2013