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Trial record 2 of 4 for:    POLO | Pancreatic Cancer

Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer (GIP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00813696
Recruitment Status : Unknown
Verified December 2008 by Istituti Tumori Giovanni Paolo II.
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2008
Last Update Posted : December 23, 2008
Sponsor:
Collaborators:
Gruppo Oncologico Italia Meridionale
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Gruppo Oncologico Italiano di Ricerca Clinica
Cattedra di Endocrinochirurgia, Università di Verona
Information provided by:
Istituti Tumori Giovanni Paolo II

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine Drug: cisplatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Study Start Date : April 2002
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : September 2009


Arm Intervention/treatment
Experimental: A
cisplatin + gemcitabine
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

Active Comparator: B
gemcitabine
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




Primary Outcome Measures :
  1. overall survival [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. clinical benefit response [ Time Frame: baseline and at end of every cycle of therapy ]
  2. quality of life [ Time Frame: baseline and at end of every cycle of therapy ]
  3. objective response [ Time Frame: after 7 weeks of therapy ]
  4. time to progression [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813696


Locations
Show Show 45 study locations
Sponsors and Collaborators
Istituti Tumori Giovanni Paolo II
Gruppo Oncologico Italia Meridionale
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Gruppo Oncologico Italiano di Ricerca Clinica
Cattedra di Endocrinochirurgia, Università di Verona
Investigators
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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
Principal Investigator: Ciro Gallo, M.D., Ph.D. University of Campania "Luigi Vanvitelli"
Principal Investigator: Francesco Perrone, M.D., Ph.D. National Cancer Institute, Naples
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Giuseppe Colucci, GOIM
ClinicalTrials.gov Identifier: NCT00813696    
Other Study ID Numbers: GIP-1
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: December 23, 2008
Last Verified: December 2008
Keywords provided by Istituti Tumori Giovanni Paolo II:
chemotherapy
advanced cancer
inoperable
Stage II, III, IV
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs