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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
docetaxel
gemcitabine hydrochloride
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Jules Bordet
  • Hopital Universitaire Erasme
  • U.Z. Gasthuisberg
  • National Cancer Institute of Egypt
  • CHU Ambroise Pare
  • Centre Alexis Vautrin
  • Institut Gustave Roussy
  • Klinikum St. Marien
  • Universitaetsklinik und Strahlenklinik - Essen
  • Klinikum der J.W. Goethe Universitaet
  • Marien Hospital
  • Hermann-Holthusen Institute for Radiotherapy
  • Medizinische Hochschule Hannover
  • Praxis Innere Medizin
  • Klinikum der Universitaet Ulm
  • Saint Laurentius Ziekenhuis
  • Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
  • Dokuz Eylul University School of Medicine
  • Beatson Oncology Centre

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00004884
Brief Title
Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Official Title
Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
March 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manfred Lutz, MD
Organizational Affiliation
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Klinikum St. Marien
City
Amberg
ZIP/Postal Code
D-92224
Country
Germany
Facility Name
Universitaetsklinik und Strahlenklinik - Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Klinikum der J.W. Goethe Universitaet
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Marien Hospital
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Hermann-Holthusen Institute for Radiotherapy
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Praxis Innere Medizin
City
Neustadt
ZIP/Postal Code
D-01844
Country
Germany
Facility Name
Klinikum der Universitaet Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
Saint Laurentius Ziekenhuis
City
Roermond
ZIP/Postal Code
6043 CV
Country
Netherlands
Facility Name
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Dokuz Eylul University School of Medicine
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Beatson Oncology Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16361622
Citation
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. doi: 10.1200/JCO.2005.02.1980.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

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

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