Clinical trial NCT00075452: Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
Official title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-01-12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Detailed description: OBJECTIVES:

Primary

* Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

* Compare the time of response in patients treated with these regimens.
* Compare the clinical benefit of and tolerance to these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the progression-free survival of patients treated with these regimens.

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

* Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed pancreatic adenocarcinoma

  * Locally advanced or metastatic disease
  * Unresectable disease
* Measurable disease

  * At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
* No adenocarcinoma of the bile ducts or ampulla of Vater
* No known brain metastases

PATIENT CHARACTERISTICS:

Age

* 18 to 75

Performance status

* ECOG 0-2 OR
* Karnofsky 60-100%

Life expectancy

* More than 12 weeks

Hematopoietic

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic

* Bilirubin less than 1.5 times normal
* Alkaline phosphatase less than 5 times normal

Renal

* Creatinine less than 1.5 times normal
* No uncontrolled or persistent hypercalcemia

Cardiovascular

* No serious cardiac failure

Pulmonary

* No serious respiratory failure

Other

* Pain must be stabilized or controlled before initiation of study treatment
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other untreatable malignant tumor
* No serious psychological, familial, social, or geographical condition that would preclude study participation
* No neuropathy that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy

Endocrine therapy

* No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

* No prior radiotherapy

Surgery

* Not specified

Primary outcomes:
measure: Overall survival
Secondary outcomes:
measure: Time to response
measure: Clinical benefit
measure: Quality of life
measure: Progression-free survival
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Beauvais
country: France
facility: C.H.G. Beauvais
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Boulogne Billancourt
country: France
facility: CHU Ambroise Pare
city: Briis Sous Forges
country: France
facility: CMC Bligny
city: Chartres
country: France
facility: Hopital Louis Pasteur
city: Clermont Ferrand
country: France
facility: Chu-Hopital Gabriel Montpied
city: Clichy
country: France
facility: Hopital Beaujon
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Dijon
country: France
facility: Hopital Drevon
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental
city: La Rochelle
country: France
facility: Hopital Saint - Louis
city: Lagny Sur Marne
country: France
facility: Centre Hospitalier de Lagny
city: Le Chesnay
country: France
facility: Hopital Andre Mignot
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Le Mans
country: France
facility: C. H. Du Mans
city: Libourne
country: France
facility: Hopital Robert Boulin
city: Lille
country: France
facility: Centre Hospital Universitaire Hop Huriez
city: Lyon
country: France
facility: Clinique Saint Jean
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Metz
country: France
facility: Hopital Notre-Dame de Bon Secours
city: Montfermeil
country: France
facility: Intercommunal Hospital
city: Neuilly Sur Seine
country: France
facility: American Hospital of Paris
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Bichat - Claude Bernard
city: Paris
country: France
facility: Hopital de la Croix St. Simon
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Saint Antoine
city: Paris
country: France
facility: CHU Pitie-Salpetriere
city: Paris
country: France
facility: Hopital Tenon
city: Pau
country: France
facility: Maison Medicale Marzet
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Pontoise
country: France
facility: Clinique Ste - Marie
city: Reims
country: France
facility: Polyclinique De Courlancy
city: Saumur
country: France
facility: C. H. De Saumur
city: Senlis
country: France
facility: C.H. Senlis
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Hopital Saint Antoine
name: Christophe Louvet, MD, PhD
References:
citation: Huguet F, Andre T, Hammel P, Artru P, Balosso J, Selle F, Deniaud-Alexandre E, Ruszniewski P, Touboul E, Labianca R, de Gramont A, Louvet C. Impact of chemoradiotherapy after disease control with chemotherapy in locally advanced pancreatic adenocarcinoma in GERCOR phase II and III studies. J Clin Oncol. 2007 Jan 20;25(3):326-31. doi: 10.1200/JCO.2006.07.5663.
citation: Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, Andre T, Zaniboni A, Ducreux M, Aitini E, Taieb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 2005 May 20;23(15):3509-16. doi: 10.1200/JCO.2005.06.023.