Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments gemcitabine, cisplatin
Phase phase 3
Sponsor Istituti Tumori Giovanni Paolo II
Collaborator Gruppo Oncologico Italia Meridionale
Start date April 2002
End date March 2009
Trial size 400 participants
Trial identifier NCT00813696, GIP-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
cisplatin + gemcitabine
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
cisplatin
25 mg/m2 IV on days 1, 8, and 15 every 4 weeks
(Active Comparator)
gemcitabine
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

Primary Outcomes

Measure
overall survival
time frame: 9 months

Secondary Outcomes

Measure
clinical benefit response
time frame: baseline and at end of every cycle of therapy
quality of life
time frame: baseline and at end of every cycle of therapy
objective response
time frame: after 7 weeks of therapy
time to progression
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)
Principal investigator Giuseppe Colucci, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by Istituti Tumori Giovanni Paolo II.