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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
Both
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
administration

- 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
arrhythmia

- 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:

Interventional

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:

sanofi-avents

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

PM_L_0126

NCT ID:

NCT00261092

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Pancreatic Neoplasms
  • Neoplasms
  • Pancreatic Neoplasms

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