Know Cancer

forgot password

Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Pancreatic Neoplasms

Thank you

Trial Information

Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer

Inclusion Criteria:

- Histologically proven adenocarcinoma of the pancreas

- Metastatic or locally advanced, non resectable disease(Non resectable disease will be
determined by the investigators with clinical data)

- Uni-dimensionally measurable disease as defined by RECIST (primary or secondary
tumors>2cm using conventional CT scan or ≥1cm with spiral CT scan)

- No previous chemo or radiotherapy, but postoperative radiotherapy as a adjuvant
therapy for non-target lesion is permitted

- Karnofsky Performance Status (KPS) ≥60

- No known Central Nervous System metastases

- No sensory neuropathy at inclusion

- Biological and hematological evaluation < 2 weeks prior to treatment administration:

- Neutrophils ≥ 1500/ mm3

- Platelets ≥ 100,000/mm3

- Alkaline phosphatases< 5X ULN(upper Limits of Normal) and Bilirubin < 1.5X ULN

- SGOT,SGPT <2.5 X ULN if no liver metastasis

- SGOT,SGPT <5 X ULN if liver metastasis

- Creatinine < 1.5 X ULN

- Baseline imaging (CT scan or Magnetic Resonance Imaging) <3 weeks before treatment

- Men and women who are fertile must use a medically acceptable contraceptive
throughout the treatment period and for 3 months following cessation of treatment
with oxaliplatin. Subjects must be made aware, before entering this trial of the risk
of becoming pregnant or in fathering children

Exclusion Criteria:

- Corticotherapy except for anti-emetic purpose

- Pregnant or breast feeding women (Documentation of a negative pregnancy test must be
available for premenopausal women with intact reproductive organs)

- Uncontrolled congestive heart failure or angina pectoris, or hypertension or

- Uncontrolled or persistent hypercalcemia

- History of significant neurologic or psychiatric disorders

- Vater ampulomas and biliary tract adenocarcinomas

- Other -non cured- malignancies

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate based on RECIST criteria

Principal Investigator

Won-Sik Lee, MD

Investigator Role:

Study Director

Investigator Affiliation:



South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Pancreatic Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms