Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer
NCT ID: NCT00952029
Last Updated: 2020-03-30
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
492 participants
INTERVENTIONAL
2010-03-31
2018-01-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.
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Detailed Description
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Primary
* Compare disease-control duration in patients with metastatic colorectal cancer receiving FOLFIRI chemotherapy in combination with bevacizumab with or without bevacizumab maintenance therapy.
Secondary
* Determine objective response rate.
* Determine non-hematologic grade 3-4 (except alopecia) toxicity rate.
* Determine overall toxicity rate.
* Determine duration of chemotherapy-free interval.
* Determine progression-free survival.
* Determine overall survival.
* Determine time-to-treatment failure.
* Determine quality of life (EORTC QLQ-C30).
* Complete geriatric evaluation.
OUTLINE: This is a multicenter study. Patients are stratified according to cancer center, primary tumor (resected vs unresected), and Köhne criteria (low vs intermediate vs high). Patients are randomized to 1 of 2 treatment arms.
* Arm A: Patients receive FOLFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1-2. Chemotherapy treatment repeats every 2 weeks for 12 courses. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks during chemotherapy. Patients then receive bevacizumab maintenance therapy once every 2 weeks during the chemotherapy-free interval.
* Arm B: Patients receive FOLFIRI chemotherapy and bevacizumab as in arm A. Patients receive no treatment during the chemotherapy-free interval.
In all arms, the chemotherapy treatment and the chemotherapy-free interval treatment repeats in the absence of disease progression during the chemotherapy portion or unacceptable toxicity. Patients who progress during the chemotherapy-free interval will receive 12 more courses of chemotherapy.
All patients complete quality of life questionnaires (QLQ-30) and patients ≥ 75 also complete the geriatric questionnaire at baseline and every 8 weeks during study treatment.
After completion of study treatment, patients are followed up every 8 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
bevacizumab
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
No maintenance with bevacizumab
FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance
bevacizumab
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Interventions
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bevacizumab
FOLFIRI regimen
fluorouracil
irinotecan hydrochloride
leucovorin calcium
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed colorectal cancer
* Metastatic disease
* Not a candidate for curative surgery
* At least 1 tumor target measurable by RECIST criteria
* No metastasis potentially resectable after receiving chemotherapy
* No occlusive tumors
* No macronodular peritoneal carcinomatosis
* No known or suspected CNS metastases
PATIENT CHARACTERISTICS:
* OMS status 0-2
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastases)
* Creatinine ≤ 1.5 times ULN
* Proteinuria ≤1 g
* Not pregnant or nursing
* No gastroduodenal ulcer, wound, or fractured bone
* No acute or subacute intestinal occlusion or history of inflammatory bowel disease or large resection of small bowel
* No clinically relevant coronary artery disease or a history of a myocardial infarction within the last 6 months
* No uncontrolled hypertension while receiving chronic medication
* No other malignancy within the past 5 years except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
* No medical or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study
PRIOR CONCURRENT THERAPY:
* See Patient Characteristics
* No prior chemotherapy for metastatic disease
* Adjuvant chemotherapy allowed provided it was completed \> 6 months ago
* No prior irinotecan or other antiangiogenic therapy
* At least 4 weeks since surgery (except for diagnostic biopsy) or irradiation
* No other drugs not allowed for medical reasons
* Concurrent oral anticoagulants (e.g., coumadin, warfarin) allowed provided the INR is closely monitored
* A change of anticoagulants to low-molecular weight heparin is preferred
18 Years
120 Years
ALL
No
Sponsors
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Federation Francophone de Cancerologie Digestive
OTHER
Responsible Party
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Principal Investigators
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Thomas Aparicio, Pr
Role: PRINCIPAL_INVESTIGATOR
Hopital Avicenne BOBIGNY
Locations
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CH
Abbeville, , France
Centre Radiothérapie et Oncologie de Moyenne Garonne
Agen, , France
CHU
Amiens, , France
Centre Paul Papin
Angers, , France
CHU
Angers, , France
Pringny
Annecy, , France
CH
Aubenas, , France
CH
Auxerre, , France
Polyclinique Sainte Marguerite
Auxerre, , France
CH
Avignon, , France
Ch
Bayonne, , France
CH
Beauvais, , France
CHU
Besançon, , France
Centre Pierre Curie
Beuvry, , France
CH
Béziers, , France
Ch
Blois, , France
Hôpital Avicenne
Bobigny, , France
Clinique Tivoli
Bordeaux, , France
Institut Bergonié
Bordeaux, , France
CH
Bourg-en-Bresse, , France
CH
Bourges, , France
CH
Cahors, , France
CHIC
Castres, , France
Hôpital Privé Sainte Marie
Chalon-sur-Saône, , France
CH
Cholet, , France
Clinique des Cèdres
Cornebarrieu, , France
CH
Créteil, , France
CH
Dax, , France
Centre Léonard de Vinci
Dechy, , France
Centre Leclerc
Dijon, , France
CHU
Dijon, , France
Parc
Dijon, , France
CH
Dunkirk, , France
CH
Elbeuf, , France
CH
Fréjus, , France
Hôpital Chicas
Gap, , France
CH
La Roche-sur-Yon, , France
CH
Langres, , France
CH
Le Mans, , France
CH
Libourne, , France
Centre Bourgogne
Lille, , France
Clinique F. Chenieux
Limoges, , France
CH
Longjumeau, , France
CHBS
Lorient, , France
Centre Léon Bérard
Lyon, , France
CHU Edouard Herriot
Lyon, , France
Clinique de la Sauvegarde
Lyon, , France
Clinique Mutualiste
Lyon, , France
Croix Rousse
Lyon, , France
Hôpital Saint Joseph
Lyon, , France
CHU La Timone
Marseille, , France
Hôpital A. Paré
Marseille, , France
Hôpital Nord
Marseille, , France
Hôpital Saint Joseph
Marseille, , France
CH
Mâcon, , France
CH
Meaux, , France
CHG
Mont-de-Marsan, , France
CH
Montauban, , France
CH
Montélimar, , France
CH Le Raincy
Montfermeil, , France
Centre Cancérologique
Montpellier, , France
Centre Azuréen
Mougins, , France
Hôpital Saint Herblain
Nantes, , France
Polyclinique
Narbonne, , France
CH
Neuilly-sur-Seine, , France
Centre Antoine Lacassagne
Nice, , France
L'Archet II
Nice, , France
CHU
Nîmes, , France
Clinique Valdegour, Centre ONCOGARD - Institut de Cancérologie du Gard
Nîmes, , France
CHR (Oncologie Médicale)
Orléans, , France
CHR
Orléans, , France
Clinique Les Murlins
Orléans, , France
Bichat
Paris, , France
CHU - Kremlin Bicêtre
Paris, , France
HEGP
Paris, , France
Hôpital Saint Louis
Paris, , France
Pitié Salpetière
Paris, , France
CH
Pau, , France
CH
Perpignan, , France
CH
Pessac, , France
CH
Périgueux, , France
CH
Rang-du-Fliers, , France
CH
Reims, , France
CH
Romans-sur-Isère, , France
CH
Roubaix, , France
CHU
Rouen, , France
CH
Saint-Brieuc, , France
Clinique Armoricaine
Saint-Brieuc, , France
HIA Begin
Saint-Mandé, , France
Centre Joliot Curie
Saint-Martin-Boulogne, , France
Clinique Mutualiste
Saint-Nazaire, , France
CHU Saint Etienne
Saint-Priest-en-Jarez, , France
Centre Paul Strauss
Strasbourg, , France
CHU Trousseau
Tours, , France
CH
Valence, , France
Clinique Générale
Valence, , France
CH
Valenciennes, , France
CAC
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
Clinique
Vienne, , France
CH
Villejuif, , France
Hôpital Intercommunal
Villeneuve-Saint-Georges, , France
Countries
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References
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Aparicio T, Linot B, Le Malicot K, Bouche O, Boige V, Francois E, Ghiringhelli F, Legoux JL, Ben Abdelghani M, Phelip JM, Faroux R, Dahan L, Taieb J, Bedenne L. FOLFIRI+bevacizumab induction chemotherapy followed by bevacizumab or observation in metastatic colorectal cancer, a phase III trial (PRODIGE 9--FFCD 0802). Dig Liver Dis. 2015 Apr;47(4):271-2. doi: 10.1016/j.dld.2015.01.146. Epub 2015 Jan 20. No abstract available.
Aparicio T, Ghiringhelli F, Boige V, Le Malicot K, Taieb J, Bouche O, Phelip JM, Francois E, Borel C, Faroux R, Dahan L, Jacquot S, Genet D, Khemissa F, Suc E, Desseigne F, Texereau P, Lepage C, Bennouna J; PRODIGE 9 Investigators. Bevacizumab Maintenance Versus No Maintenance During Chemotherapy-Free Intervals in Metastatic Colorectal Cancer: A Randomized Phase III Trial (PRODIGE 9). J Clin Oncol. 2018 Mar 1;36(7):674-681. doi: 10.1200/JCO.2017.75.2931. Epub 2018 Jan 18.
Aparicio T, Bennouna J, Le Malicot K, Boige V, Taieb J, Bouche O, Phelip JM, Francois E, Borel C, Faroux R, Dahan L, Bachet JB, Egreteau J, Kaminsky MC, Gornet JM, Cojocarasu O, Gasmi M, Guerin-Meyer V, Lepage C, Ghiringhelli F; for PRODIGE investigators/collaborators. Predictive factors for early progression during induction chemotherapy and chemotherapy-free interval: analysis from PRODIGE 9 trial. Br J Cancer. 2020 Mar;122(7):957-962. doi: 10.1038/s41416-020-0735-8. Epub 2020 Feb 4.
Guilloteau A, Abrahamowicz M, Boussari O, Jooste V, Aparicio T, Quantin C, Le Malicot K, Binquet C. Impact of time-varying cumulative bevacizumab exposures on survival: re-analysis of data from randomized clinical trial in patients with metastatic colo-rectal cancer. BMC Med Res Methodol. 2021 Jan 9;21(1):14. doi: 10.1186/s12874-020-01202-9.
Dohan A, Gallix B, Guiu B, Le Malicot K, Reinhold C, Soyer P, Bennouna J, Ghiringhelli F, Barbier E, Boige V, Taieb J, Bouche O, Francois E, Phelip JM, Borel C, Faroux R, Seitz JF, Jacquot S, Ben Abdelghani M, Khemissa-Akouz F, Genet D, Jouve JL, Rinaldi Y, Desseigne F, Texereau P, Suc E, Lepage C, Aparicio T, Hoeffel C; PRODIGE 9 Investigators and PRODIGE 20 Investigators. Early evaluation using a radiomic signature of unresectable hepatic metastases to predict outcome in patients with colorectal cancer treated with FOLFIRI and bevacizumab. Gut. 2020 Mar;69(3):531-539. doi: 10.1136/gutjnl-2018-316407. Epub 2019 May 17.
Other Identifiers
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FFCD-PRODIGE-9
Identifier Type: -
Identifier Source: secondary_id
FFCD-0802
Identifier Type: -
Identifier Source: secondary_id
EU-20912
Identifier Type: -
Identifier Source: secondary_id
EU-21030
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2008-007928-25
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2009-017996-11
Identifier Type: -
Identifier Source: secondary_id
PRODIGE 9
Identifier Type: -
Identifier Source: org_study_id
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