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 3
  • Study Type

  • Status

    Unknown status
  • Study Participants

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.
Study Started
Apr 30
Primary Completion
Mar 31
Study Completion
Sep 30
Last Update
Dec 23

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

A Experimental

cisplatin + gemcitabine

B Active Comparator



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.
No Results Posted