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

Study Overview
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Brief Summary
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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.

Official Title
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Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine
* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>cisplatin + gemcitabine | Drug: gemcitabine<br>* 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<br>Drug: cisplatin<br>* 25 mg/m2 IV on days 1, 8, and 15 every 4 weeks<br>|
| Active Comparator: B<br>gemcitabine | Drug: gemcitabine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, advanced cancer, inoperable, Stage II, III, IV