Clinical trial NCT00268411: Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Official title: Phase II Randomisee Dans Les Adenocarcinomes Metastatiques Du Pancreas: Gemox Et Gemox Simplifie. [GEMOX]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2005-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving both of these drugs on the same day is more effective than giving them on different days.

PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.

Detailed description: OBJECTIVES:

Primary

* Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with two different schedules of gemcitabine hydrochloride and oxaliplatin.

Secondary

* Compare the clinical benefits and tolerability of these regimens in these patients.
* Compare the progression-free and overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the participating center and ECOG performance status (0 or 1 vs 2). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2.
* Arm II: Patients receive gemcitabine hydrochloride IV over 100 minutes followed by oxaliplatin IV over 2 hours on day 1.

In both arms, treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the pancreas

  * Metastatic disease
* Measurable disease (primary tumor or metastasis)

  * At least 1 cm in diameter by spiral CT scan
* No ampulla of Vater carcinoma or biliary adenocarcinoma
* No known brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy more than 12 weeks
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Alkaline phosphatase \< 5 times normal
* Bilirubin \< 1.5 times normal
* Creatinine \< 1.5 times normal
* No pre-existing neuropathy
* No unstable or uncontrolled pain
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No serious cardiovascular disease
* No serious respiratory disease
* No uncontrolled or persistent hypercalcemia
* No psychological, familial, social, or geographical condition that would preclude study treatment
* No other active malignancy

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy
* No concurrent corticosteroids

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Clinical benefits and tolerability
measure: Progression-free and overall survival
Other outcomes:
Locations:
city: Avignon
country: France
facility: Hopital Duffaut
city: Beauvais
country: France
facility: C.H.G. Beauvais
city: Dijon
country: France
facility: Hopital Drevon
city: Dreux
country: France
facility: Centre Hospitalier de Dreux
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: La Rochelle
country: France
facility: Hopital Saint - Louis
city: Le Coudray
country: France
facility: Hopital Louis Pasteur - Le Coudray
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lormont
country: France
facility: Polyclinique des Quatre Pavillons
city: Lyon
country: France
facility: Clinique Saint Jean
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: Hopital Tenon
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Senlis
country: France
facility: C.H. Senlis
Study officials:
affiliation: Hopital Saint Antoine
name: Christophe Louvet, MD, PhD
role: STUDY_CHAIR
References: