Clinical trial NCT00261092: GEMOX: Oxaliplatin in Pancreatic Cancer
Official title: Phase II Multicenter, Open Label Study of Oxaliplatin Combined With Gemcitabine(GEMOX) in Advanced and Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

* To evaluate overall response rate (based on RECIST criterion)

Secondary objective:

* To evaluate time to progression, clinical benefit, quality of life and safety


Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate based on RECIST criteria
Secondary outcomes:
measure: Time to progression
measure: Overall survival
measure: Clinical benefit
measure: Quality of life
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis
Study officials:
affiliation: sanofi-avents
name: Won-Sik Lee, MD
role: STUDY_DIRECTOR
References: