Title
Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer
Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Phase
Phase 3Lead Sponsor
Istituti Tumori Giovanni Paolo IIStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Pancreatic CancerIntervention/Treatment
gemcitabine cisplatin ...Study Participants
400The 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.
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
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.
