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

• Status: Unknown status
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituti Tumori Giovanni Paolo II
• Collaborators: Cattedra di Endocrinochirurgia, Università di Verona; Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente; Gruppo Oncologico Italia Meridionale; Gruppo Oncologico Italiano di Ricerca Clinica
• Treatments: Cisplatin; Gemcitabine

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.