Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Pancreatic Cancer Clinical Trial

Official title:

Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303758
• Other study ID #: CDR0000453841
• Secondary ID: FFCD-0301EU-2054
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2006
• Last updated: March 3, 2014
• Start date: October 2005
• Est. completion date: March 2012

Study information

• Verified date: December 2006
• Source: Federation Francophone de Cancerologie Digestive
• 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 fluorouracil, leucovorin, cisplatin, and gemcitabine, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

Primary

• Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.

Secondary

• Compare progression-free survival of patients treated with these regimens.

• Compare the toxicity of these regimens in these patients.

• Compare the quality of life of patients treated with these regimens.

• Compare the percentage of these patients needing second-line therapy.

• Compare the duration of hospitalization of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

• Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.

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

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla

• Metastatic disease

• Unresectable disease

• Measurable disease, meeting the following criteria:

• No prior radiotherapy to the only site of measurable disease

• Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods

• No brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Life expectancy > 2 months

• No contraindication to chemotherapy

• Creatinine clearance > 60 mL/min

• Absolute neutrophil count = 1,500/mm³

• Platelet count = 100,000/mm³

• Alkaline phosphatase < 5 times normal

• Bilirubin = 3 mg/dL

• No coronary insufficiency

• No symptomatic cardiac disease

• Good hydration possible

• No Child-Pugh class B or C cirrhosis

• No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix

• Not pregnant or nursing

• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior palliative or adjuvant chemotherapy

• At least 4 weeks since prior radiotherapy

• No radiotherapy during or for 4 weeks after study therapy

• No other concurrent anticancer therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

• gemcitabine hydrochloride

• leucovorin calcium

Locations

Country	Name	City	State
France	Centre Hospitalier d'Abbeville	Abbeville
France	Hopital Duffaut	Avignon
France	Centre Hospitalier de Blois	Blois
France	Centre Hospitalier Universitaire Ambroise Pare - Boulogne	Boulogne
France	Centre Hospitalier Docteur Duchenne	Boulogne Sur Mer
France	C.H. Bourg En Bresse	Bourg En Bresse
France	Centre Hospitalier Pierre Oudot	Bourgoin-Jallieu
France	Centre Hospitalier Universitaire d'Amiens	Caen
France	Centre Hospitalier de Chalons-en-Champagne	Chalons-en-Champagne
France	CHR Clermont Ferrand, Hotel dieu	Clermont-Ferrand
France	Hopital Beaujon	Clichy
France	Hopital Louis Pasteur	Colmar
France	Centre de Lutte Contre le Cancer Georges-Francois Leclerc	Dijon
France	Hopital Du Bocage	Dijon
France	Centre Hospitalier Draguignan	Draguignan
France	Centre Hospitalier De Dunkerque - CHD	Dunkerque
France	Centre Hospitalier Intercommunal St. Aubin les Elbeuf	Elbeuf
France	CHU de Grenoble - Hopital de la Tronche	Grenoble
France	Clinique Pasteur	Guilherand Granges
France	Hopital Robert Boulin	Libourne
France	Centre Hospital Universitaire Hop Huriez	Lille
France	Centre Hospitalier Regional et Universitaire de Lille	Lille
France	Hopital Edouard Herriot	Lyon
France	CHU de la Timone	Marseille
France	CHU Nord	Marseille
France	Hopital Saint Joseph	Marseille
France	Centre Hospitalier de Martigues	Martigues
France	Centre Hospitalier General de Mont de Marsan	Mont-de-Marsan
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	CHR Hotel Dieu	Nantes
France	CHR D'Orleans - Hopital de la Source	Orleans
France	Hopital Bichat - Claude Bernard	Paris
France	Hopital Europeen Georges Pompidou	Paris
France	Hopital Haut Leveque	Pessac
France	Clinique Ste - Marie	Pontoise
France	CHU - Robert Debre	Reims
France	Centre Eugene Marquis	Rennes
France	Hopital Charles Nicolle	Rouen
France	Clinique Armoricaine De Radiologie	Saint Brieuc
France	Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault	Saint Martin Boulogne
France	Centre Hospitalier de Saint-Quentin	Saint-Quentin
France	Centre Hospitalier de Semur en Auxois	Semur en Auxois
France	Centre Hospitalier de Soissons	Soissons cedex
France	Hopital Universitaire Hautepierre	Strasbourg
France	Centre Hospitalier de Tarbes	Tarbes
France	Nouvelle Clinique Generale	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Federation Francophone de Cancerologie Digestive

Country where clinical trial is conducted

France, 

References & Publications (2)

Dahan L, Bonnetain F, Ychou M, Mitry E, Gasmi M, Raoul JL, Cattan S, Phelip JM, Hammel P, Chauffert B, Michel P, Legoux JL, Rougier P, Bedenne L, Seitz JF; Fédération Francophone de Cancérologie Digestive. Combination 5-fluorouracil, folinic acid and cisp — View Citation

Mitry E, Dahan L, Ychou M, et al.: LV5FU2-cisplatin followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: preliminary results of a randomized phase III trial (FFCD 0301). [Abstract] J Clin Oncol 26 (Suppl 15): A-4513, 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		2012	No
Secondary	Progression-free survival		2012	No
Secondary	Toxicity		2012	Yes
Secondary	Quality of life		2012	No
Secondary	Percentage of patients needing second-line therapy		2012	No
Secondary	Duration of hospitalization		2012	No