Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer (GIP-1)
December 22, 2008 updated by: Istituti Tumori Giovanni Paolo II
Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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ARco, Italy
- Presidio Osp. Alto Garda e Ledro
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Acquaviva delle Fonti, Italy
- Ospedal Miulli
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Ancona, Italy
- Ospedale Regionale Torrette
-
Aviano, Italy
- Centro Riferimento Oncologico
-
Bari, Italy
- Istituto Oncologico Giovanni Paolo II
-
Benevento, Italy
- Ospedale Fatebenefratelli
-
Benevento, Italy
- Azienda Ospedaliera G. Rummo
-
Bergamo, Italy
- Ospedale Riuniti
-
Biella, Italy
- Ospedale degli Infermi
-
Bolzano, Italy
- Ospedale Regionale
-
Cagliari, Italy
- Policlinico Universitario
-
Campobasso, Italy
- Ospedale A. Cardarelli
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Carpi, Italy
- Ospedale Ramazzini
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Catania, Italy
- Centro Catanese di Oncologia
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Chieti, Italy
- Università di Chieti "D'Annunzio"
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Como, Italy
- Ospedale Valduce
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Fano, Italy
- Ospedale Santa Croce
-
Ferrara, Italy
- Azienda Ospedaliera Universitaria
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Firenze, Italy
- Azienda Ospedale Careggi
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Lecce, Italy
- Azienda Ospedaliera Vito Fazzi
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Lugo, Italy
- Ospedale Umberto I
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Manerbio, Italy
- Pres. Osp. di Manerbio
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Milano, Italy
- Ospedale L. Sacco
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Milano, Italy
- Ospedale San Paolo
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Monteforte Irpino, Italy
- Ospedale G. Moscati
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Monza, Italy
- Ospedale San Gerardo
-
Napoli, Italy
- Ospedale Cardarelli
-
Napoli, Italy
- Istituto Nazionale Tumori
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Olbia, Italy
- Ospedale Civile
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Palermo, Italy
- Casa di Cura La Maddalena
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Palermo, Italy
- Policlinico Giaccone
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Pesaro, Italy
- Ospedale San Salvatore-Muraglia
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Piacenza, Italy
- Ospedale Guglielmo da Saliceto
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Potenza, Italy
- Ospedale San Carlo
-
Roma, Italy
- Ospedale Fatebenefratelli
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Roma, Italy
- Azienda Policlinico S. Andrea
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Roma, Italy
- Ospedale San Raffaele
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Roma, Italy
- Policlinico Militare Celio
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Roma, Italy
- Polo Oncologico Istituto Regina Elena
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Rovereto, Italy
- Ospedale Civile
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Rovigo, Italy
- Ospedale Civile
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S. Vito al Tagliamento, Italy
- Centro Oncologico
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Trento, Italy
- Ospedale Santa Chiara
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Treviglio, Italy
- Azienda Ospedaliera Treviglio-Caravaggio
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Vicenza, Italy
- Ospedale San Bortolo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologic or cytologic diagnosis pancreatic cancer
- inoperable stage II or stage III or IV disease(UICC, 1997)
- Age 18 to 75 years
- Karnofsky Performance status > 50
- Signed informed consent
Exclusion Criteria:
- Previous chemotherapy
- Cerebral metastases
- Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
- Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl
- Creatinine value > upper normal limit
- GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit in absence of hepatic metastases
- Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
- Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
- Inability to provide informed consent
- Inability to comply with follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: A
cisplatin + 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
25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
|
|
ACTIVE_COMPARATOR: B
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
overall survival
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
clinical benefit response
Time Frame: baseline and at end of every cycle of therapy
|
baseline and at end of every cycle of therapy
|
|
quality of life
Time Frame: baseline and at end of every cycle of therapy
|
baseline and at end of every cycle of therapy
|
|
objective response
Time Frame: after 7 weeks of therapy
|
after 7 weeks of therapy
|
|
time to progression
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Giuseppe Colucci, M.D., Istituto Tumori Giovanni Paolo II
- Principal Investigator: Roberto Labianca, M.D., Ospedale Riuniti Bergamo
- Principal Investigator: Francesco Di Costanzo, M.D., Azienda Ospedaliera Careggi
- Principal Investigator: Stefano Cascinu, M.D., Ospedale Riuniti Umberto I-Lancise-Salese
- Principal Investigator: Paolo Pederzoli, M.D., Policlinico G.B. Rossi, Verona
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2002
Primary Completion (ANTICIPATED)
March 1, 2009
Study Completion (ANTICIPATED)
September 1, 2009
Study Registration Dates
First Submitted
December 22, 2008
First Submitted That Met QC Criteria
December 22, 2008
First Posted (ESTIMATE)
December 23, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
December 23, 2008
Last Update Submitted That Met QC Criteria
December 22, 2008
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Cisplatin
Other Study ID Numbers
- GIP-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.