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

NCT00303758 | Completed Phase 3

• 3 other identifiers: CDR0000453841FFCD-0301EU-20543
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 46

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  2012

Secondary Outcomes (5)

• Progression-free survival

  2012

• Toxicity

  2012

• Quality of life

  2012

• Percentage of patients needing second-line therapy

  2012

• Duration of hospitalization

  2012

Study Arms (2)

LV5FU2 simplifié + cisplatine puis gemcitabine si progression

ACTIVE COMPARATOR

LV5FU2 simplifié + cisplatine puis gemcitabine si progression

Drug: cisplatin; Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium

gemcitabine puis LV5FU2 simplifié + cisplatine si progression

EXPERIMENTAL

gemcitabine puis LV5FU2 simplifié + cisplatine si progression

Drug: cisplatin; Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium

Interventions

cisplatin DRUG

LV5FU2 simplifié + cisplatine puis gemcitabine si progression; gemcitabine puis LV5FU2 simplifié + cisplatine si progression

fluorouracil DRUG

LV5FU2 simplifié + cisplatine puis gemcitabine si progression; gemcitabine puis LV5FU2 simplifié + cisplatine si progression

gemcitabine hydrochloride DRUG

LV5FU2 simplifié + cisplatine puis gemcitabine si progression; gemcitabine puis LV5FU2 simplifié + cisplatine si progression

leucovorin calcium DRUG

LV5FU2 simplifié + cisplatine puis gemcitabine si progression; gemcitabine puis LV5FU2 simplifié + cisplatine si progression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Study Sites (46)

Centre Hospitalier d'Abbeville

Abbeville, 80101, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

Centre Hospitalier de Blois

Blois, 41016, France

Location

Centre Hospitalier Universitaire Ambroise Pare - Boulogne

Boulogne, F-92104, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

C.H. Bourg En Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

Centre Hospitalier Universitaire d'Amiens

Caen, 14076, France

Location

Centre Hospitalier de Chalons-en-Champagne

Châlons-en-Champagne, 51000, France

Location

CHR Clermont Ferrand, Hotel dieu

Clermont-Ferrand, 63003, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Hopital Louis Pasteur

Colmar, 68024, France

Location

Hopital Du Bocage

Dijon, 21034, France

Location

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Hospitalier Draguignan

Draguignan, 83300, France

Location

Centre Hospitalier De Dunkerque - CHD

Dunkirk, 59240, France

Location

Centre Hospitalier Intercommunal St. Aubin les Elbeuf

Elbeuf, 76503, France

Location

CHU de Grenoble - Hopital de la Tronche

Grenoble, 38043, France

Location

Clinique Pasteur

Guilherand-Granges, 07500, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

CHU de la Timone

Marseille, 13385, France

Location

CHU Nord

Marseille, 13915, France

Location

Centre Hospitalier de Martigues

Martigues, 13698, France

Location

Centre Hospitalier General de Mont de Marsan

Mont-de-Marsan, 40000, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CHR Hotel Dieu

Nantes, 44093, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45100, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Clinique Ste - Marie

Pontoise, 95301, France

Location

CHU - Robert Debre

Reims, 51092, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Clinique Armoricaine De Radiologie

Saint-Brieuc, F-22015, France

Location

Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault

Saint-Martin-Boulogne, 62280, France

Location

Centre Hospitalier de Saint-Quentin

Saint-Quentin, 02321, France

Location

Centre Hospitalier de Semur en Auxois

Semur-en-Auxois, 21140, France

Location

Centre Hospitalier de Soissons

Soissons, 02209, France

Location

Hopital Universitaire Hautepierre

Strasbourg, 67098, France

Location

Centre Hospitalier de Tarbes

Tarbes, 65013, France

Location

Nouvelle Clinique Generale

Valence, 26000, France

Location

Related Publications (1)

• 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.

  PMID: 20947887 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Cisplatin; Fluorouracil; Gemcitabine; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Jean-Francois Seitz, MD

  CHU de la Timone

  STUDY CHAIR

• Jean-Louis Legoux, MD

  Hopital Haut Leveque

  STUDY CHAIR

• Pascal Hammel, MD, PhD

  Hopital Beaujon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 17, 2006
• Study Start: October 1, 2005
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 4, 2014

Record last verified: 2006-12

Locations

FR (46)