Gemcitabine Or Gemcitabine And Cisplatin In The Treatment Of Advanced Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Cancer

DRUG: gemcitabine
DRUG: cisplatin

GIP-1

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-12-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2008-12-22
First Submitted that Met QC Criteria 2008-12-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2008-12-23
First Posted (ESTIMATED) 2008-12-23	Results First Posted N/A	Last Verified 2008-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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	Measure Description	Time Frame
overall survival		9 months

Secondary Outcome Measures	Measure Description	Time Frame
clinical benefit response		baseline and at end of every cycle of therapy
quality of life		baseline and at end of every cycle of therapy
objective response		after 7 weeks of therapy
time to progression		6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

PRINCIPAL_INVESTIGATOR: Giuseppe Colucci, M.D., Istituto Tumori Giovanni Paolo II

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Colucci G, Labianca R, Di Costanzo F, Gebbia V, Carteni G, Massidda B, Dapretto E, Manzione L, Piazza E, Sannicolo M, Ciaparrone M, Cavanna L, Giuliani F, Maiello E, Testa A, Pederzoli P, Falconi M, Gallo C, Di Maio M, Perrone F; Gruppo Oncologico Italia Meridionale (GOIM); Gruppo Italiano per lo Studio dei Carcinomi dell'Apparato Digerente (GISCAD); Gruppo Oncologico Italiano di Ricerca Clinica (GOIRC). Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 2010 Apr 1;28(10):1645-51. doi: 10.1200/JCO.2009.25.4433. Epub 2010 Mar 1.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record