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)

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00813696

Acronym

GIP-1

Enrollment

400

Registered

2008-12-23

Start date

2002-04-30

Completion date

2009-09-30

Last updated

2008-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

chemotherapy, advanced cancer, inoperable, Stage II, III, IV

Brief 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.

Interventions

DRUGgemcitabine

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

DRUGcisplatin

25 mg/m2 IV on days 1, 8, and 15 every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
overall survival	9 months

Secondary

Measure	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026