Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00075452
• Other study ID #: CDR0000346480
• Secondary ID: FRE-GERCOR-GEM-G
• Status: Active, not recruiting
• Phase: Phase 3
• First received: January 9, 2004
• Last updated: July 23, 2008
• Start date: November 2003

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• oxaliplatin

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	C.H.G. Beauvais	Beauvais
France	Hopital Saint Andre	Bordeaux
France	CHU Ambroise Pare	Boulogne Billancourt
France	CMC Bligny	Briis Sous Forges
France	Hopital Louis Pasteur	Chartres
France	Chu-Hopital Gabriel Montpied	Clermont Ferrand
France	Hopital Beaujon	Clichy
France	Hopital Louis Mourier	Colombes
France	Hopital Drevon	Dijon
France	Centre Hospitalier Departemental	La Roche Sur Yon
France	Hopital Saint - Louis	La Rochelle
France	Centre Hospitalier de Lagny	Lagny Sur Marne
France	Hopital Andre Mignot	Le Chesnay
France	C. H. Du Mans	Le Mans
France	Centre Jean Bernard	Le Mans
France	Hopital Robert Boulin	Libourne
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Clinique Saint Jean	Lyon
France	Hopital de la Croix Rousse	Lyon
France	Hopital Notre-Dame de Bon Secours	Metz
France	Intercommunal Hospital	Montfermeil
France	American Hospital of Paris	Neuilly Sur Seine
France	CHU Pitie-Salpetriere	Paris
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital de la Croix St. Simon	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Saint-Louis	Paris
France	Hopital Tenon	Paris
France	Maison Medicale Marzet	Pau
France	Hopital Haut Leveque	Pessac
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Clinique Ste - Marie	Pontoise
France	Polyclinique De Courlancy	Reims
France	C. H. De Saumur	Saumur
France	C.H. Senlis	Senlis
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Country where clinical trial is conducted

France, 

References & Publications (2)

Huguet F, André 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. — View Citation

Louvet C, Labianca R, Hammel P, Lledo G, Zampino MG, André T, Zaniboni A, Ducreux M, Aitini E, Taïeb J, Faroux R, Lepere C, de Gramont A; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Secondary	Time to response			No
Secondary	Clinical benefit			No
Secondary	Quality of life			No
Secondary	Progression-free survival			No