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Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer

NCT00813696 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2008-12-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.

Conditions

Interventions

DRUG

gemcitabine

1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks

DRUG

cisplatin

25 mg/m2 IV on days 1, 8, and 15 every 4 weeks

Sponsors & Collaborators

  • Gruppo Oncologico Italia Meridionale

    collaborator OTHER

  • Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

    collaborator OTHER

  • Gruppo Oncologico Italiano di Ricerca Clinica

    collaborator OTHER

  • Cattedra di Endocrinochirurgia, Università di Verona

    collaborator UNKNOWN

  • Istituti Tumori Giovanni Paolo II

    lead NETWORK

Principal Investigators

  • Giuseppe Colucci, M.D. · Istituto Tumori Giovanni Paolo II

  • Roberto Labianca, M.D. · Ospedale Riuniti Bergamo

  • Francesco Di Costanzo, M.D. · Azienda Ospedaliera Careggi

  • Stefano Cascinu, M.D. · Ospedale Riuniti Umberto I-Lancise-Salese

  • Paolo Pederzoli, M.D. · Policlinico G.B. Rossi, Verona

  • Ciro Gallo, M.D., Ph.D. · University of Campania Luigi Vanvitelli

  • Francesco Perrone, M.D., Ph.D. · National Cancer Institute, Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2009-03-31
Completion
2009-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813696 on ClinicalTrials.gov