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

Phase 3

• Conditions: Pancreatic Cancer
• Interventions: Drug: gemcitabine; Drug: cisplatin

• Registration Number: NCT00813696
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Status Verified: 2008-12
• Study First Submitted: 2008-12-22
• Study First Submitted QC: 2008-12-22
• Last Update Submitted: 2008-12-22
• Study First Posted: 2008-12-23
• Last Update Posted: 2008-12-23
• Primary Completion: 2009-03
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	gemcitabine	cisplatin + gemcitabine
A	cisplatin	cisplatin + gemcitabine
B	gemcitabine	gemcitabine

Primary Outcome Measures

Name	Time	Method
overall survival	9 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (42)

Ospedal Miulli; 🇮🇹 Acquaviva delle Fonti, Italy

Ospedale Regionale Torrette; 🇮🇹 Ancona, Italy

Presidio Osp. Alto Garda e Ledro; 🇮🇹 ARco, Italy

Centro Riferimento Oncologico; 🇮🇹 Aviano, Italy

Istituto Oncologico Giovanni Paolo II; 🇮🇹 Bari, Italy

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, Italy

Ospedale Fatebenefratelli; 🇮🇹 Roma, Italy

Ospedale Riuniti; 🇮🇹 Bergamo, Italy

Ospedale degli Infermi; 🇮🇹 Biella, Italy

Ospedale Regionale; 🇮🇹 Bolzano, Italy

Scroll for more (32 remaining)