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

NCT ID: NCT00303758

Last Updated: 2014-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2012-03-31

Brief 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.

Detailed 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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LV5FU2 simplifié + cisplatine puis gemcitabine si progression

LV5FU2 simplifié + cisplatine puis gemcitabine si progression

Group Type: ACTIVE_COMPARATOR

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

gemcitabine puis LV5FU2 simplifié + cisplatine si progression

gemcitabine puis LV5FU2 simplifié + cisplatine si progression

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

Interventions

cisplatin

Intervention Type: DRUG

fluorouracil

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

leucovorin calcium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federation Francophone de Cancerologie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Francois Seitz, MD

Role: STUDY_CHAIR

CHU de la Timone

Jean-Louis Legoux, MD

Role: STUDY_CHAIR

Hopital Haut Leveque

Pascal Hammel, MD, PhD

Role: STUDY_CHAIR

Hopital Beaujon

Locations

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, , France

Centre Hospitalier Universitaire d'Amiens

Caen, , France

Centre Hospitalier de Chalons-en-Champagne

Châlons-en-Champagne, , France

CHR Clermont Ferrand, Hotel dieu

Clermont-Ferrand, , France

Hopital Beaujon

Clichy, , France

Hopital Louis Pasteur

Colmar, , France

Hopital Du Bocage

Dijon, , France

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, , France

Centre Hospitalier Draguignan

Draguignan, , France

Centre Hospitalier De Dunkerque - CHD

Dunkirk, , 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

Hopital Saint Joseph

Marseille, , France

CHU de la Timone

Marseille, , France

CHU Nord

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

Orléans, , France

Hopital Europeen Georges Pompidou

Paris, , France

Hopital Bichat - Claude Bernard

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, , France

Hopital Universitaire Hautepierre

Strasbourg, , France

Centre Hospitalier de Tarbes

Tarbes, , France

Nouvelle Clinique Generale

Valence, , France

Countries

France

References

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; Federation Francophone de Cancerologie Digestive. Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301). Gut. 2010 Nov;59(11):1527-34. doi: 10.1136/gut.2010.216135.

Reference Type: RESULT

PMID: 20947887 (View on PubMed)

Other Identifiers

FFCD-0301

Identifier Type: -

Identifier Source: secondary_id

EU-20543

Identifier Type: -

Identifier Source: secondary_id

CDR0000453841

Identifier Type: -

Identifier Source: org_study_id