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

Pancreatic Cancer Clinical Trial

Official title:

Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004884
• Other study ID #: EORTC-40984
• Secondary ID: EORTC-40984
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: September 20, 2012
• Start date: July 1999

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. primary completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• cisplatin

• docetaxel

• gemcitabine hydrochloride

Locations

Country	Name	City	State
Belgium	Hopital Universitaire Erasme	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	U.Z. Gasthuisberg	Leuven
Egypt	National Cancer Institute of Egypt	Cairo
France	CHU Ambroise Pare	Boulogne Billancourt
France	Centre Alexis Vautrin	Vandoeuvre-les-Nancy
France	Institut Gustave Roussy	Villejuif
Germany	Klinikum St. Marien	Amberg
Germany	Universitaetsklinik und Strahlenklinik - Essen	Essen
Germany	Klinikum der J.W. Goethe Universitaet	Frankfurt
Germany	Marien Hospital	Hagen
Germany	Hermann-Holthusen Institute for Radiotherapy	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Praxis Innere Medizin	Neustadt
Germany	Klinikum der Universitaet Ulm	Ulm
Netherlands	Saint Laurentius Ziekenhuis	Roermond
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology	Warsaw
Turkey	Dokuz Eylul University School of Medicine	Izmir
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  Egypt,  France,  Germany,  Netherlands,  Poland,  Turkey,  United Kingdom, 

References & Publications (2)

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.

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 Organisati — View Citation