Bevacizumab in Extensive Small Cell Lung Cancer
CPC
Randomized Phase II-III Study of Bevacizumab 7,5 mg/kg in Combination With Chemotherapy Versus Chemotherapy in Extensive-Disease Small-Cell Lung Cancer After Response to Chemotherapy : PCDE (cisPlatin - Cyclophosphamide - epiDoxorubicin - Etoposide) or PE (cisPlatin - Etoposide)
2 other identifiers
interventional
143
1 country
60
Brief Summary
Despite the fact that a substantial response rate may be obtained in small-cell lung cancers (using double-drug chemotherapy: cisplatin-etoposide, PE), a cure remains an exception. More aggressive regimens remain controversial and recent attempts at increasing dose-intensity have been restricted to patients with a more favourable presentation. Bevacizumab is a humanized monoclonal antibody which binds to VEGF (Vascular Endothelial Growth Factor). In association with double-drug standard chemotherapies, it has been proven that bevacizumab can improve survival of previously untreated advanced non-small-cell lung cancers (NSCLC), compared to chemotherapy without bevacizumab). Such promising effects on NSCLC deserve to be tested on small-cell lung cancers. In this trial (IFCT-0802), standard chemotherapy (PCDE or PE) will be compared to experimental treatment (PCDE or PE + bevacizumab 7.5 mg/kg) for previously untreated SCLC patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Typical duration for phase_2
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedMarch 10, 2016
March 1, 2016
2.8 years
July 1, 2009
March 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response rate (complete response + partial response)
6 weeks after randomization
Secondary Outcomes (4)
Progression-free survival
12 weeks
Complete response length
12 weeks
Quality of life
12 weeks
Toxicities
12 weeks
Study Arms (2)
Arm A
ACTIVE COMPARATOR4 additional cycles of chemotherapy
Arm B
EXPERIMENTAL4 additional cycles of chemotherapy + bevacizumab
Interventions
PCDE: cisPlatin 75 mg/m² D2 ; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles
PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression PE: cisPlatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 4 cycles Bevacizumab 7.5 mg/kg, D1, until progression
PCDE: cisPlatin 75 mg/m² D2; Cyclophosphamide 300 mg/m² D1 to D3; 4'-epiDoxorubicin 30 mg/m² D1; Etoposide 75 mg/m² D1 to D3, 2 cycles PE: cisplatin 80 mg/m², D2; Etoposide 120 mg/m² D1 to D3, 2 cycles
Eligibility Criteria
You may qualify if:
- Small-Cell Lung Cancer histologically or cytologically proved
- Extended disease as defined by Veteran's Administration Lung Cancer Group (VALG)
- At least one unidimensionally measurable lesion (RECIST criterion)
- Age between 18 and 75 years
- Weight loss \< 10% for the last three month
- Performance Status (PS)≤ 2
- Creatininemia \< 110 µmol/L and creatinin clearance \> 60 mL/min
- Neutrophils ≥ 1,500/µL and platelets ≥ 100,000/µL
- Bilirubin ≤ 1.5 x normal value
- Transaminases, Alkaline Phosphatase ≤ 2.5 x ULN excepted in case of liver metastasis (5xULN)
- Left ventricular ejection fraction (measured by echocardiographic or isotopic method) \> 50% if PCDE is planned
- Electrocardiogram without uncontrolled coronaropathy
- Signed informed consent
- Randomization Criteria (to be checked during the randomization (week 0)):
- Partial or complete tumoral response as defined by RECIST
- +1 more criteria
You may not qualify if:
- Non-Small-Cell Lung Cancer or mixed cancer (small-cell / non-small-cell)
- Previous antitumoral treatment of the small-cell lung cancer (chemotherapy, radiotherapy, immunotherapy, surgery)
- Non-extended disease as defined by VALG
- Natremia \< 125 mmol/L
- Hypercalcemia whereas a corrective treatment
- Pathology contra-indicating the hyper-hydration
- Hemoptysis in the last three months
- Tumor invading large vessels or invading the proximal trachea-bronchial tree (visible at the medical imagery). Investigator or radiologist must reject tumors adjoining, merging or extending to large vessel's lumen (for example : pulmonary artery, superior vena cava)
- Symptomatic cerebral or meningeal metastasis
- Other cancer in progress or medical history of cancer in the five last years (excepted basal cell carcinoma or in situ cervical cancer of the uterus.
- Important surgical intervention (including surgical biopsy), traumatic lesion during 28 days before starting the treatment, or anticipation of an important surgical intervention during the study
- Minor surgical intervention, including implanting permanent catheter during the 24 hours before the first administration of bevacizumab
- Unhealed wound, evolutive gastroduodenal ulcer, fractured bone
- Ongoing or recent use of aspirin (during 10 days before the first administration of bevacizumab) (\>325 mg/day) or use of another platelet aggregation inhibitor (dipyridamole, ticlopidine, clopidogrel \> 75 mg/day), or ongoing or recent use of a therapeutic dose (during 10 days before the first administration of bevacizumab) of anticoagulant or thrombolytic drugs per os or in parenteral injection. Prophylactic use of anticoagulant drug is allowed
- Medical history or genetic predisposition to bleeding or coagulopathy
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Annemasse - CH
Ambilly, 74100, France
Angers - CHU
Angers, 49000, France
Armentières - CH
Armentières, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Centre F. Baclesse
Caen, 14000, France
CHU - Pneumologie
Caen, 14000, France
Cahors - CH
Cahors, 46000, France
Chauny - CH
Chauny, France
Chalons-en-Champagne - CH
Châlons-en-Champagne, France
Hôpital Percy-Armées - Pneumologie
Clamart, 92140, France
Clermont Ferrand - CHU
Clermont-Ferrand, 63000, France
Colmar - CH
Colmar, 68000, France
CH - Compiègne
Compiègne, 60300, France
Créteil - CHI
Créteil, 94000, France
Dijon - CAC
Dijon, 21000, France
Dijon - CHU
Dijon, 63000, France
Draguignan - CH
Draguignan, 83300, France
CHU Grenoble - pneumologie
Grenoble, 38000, France
Harfleur - Clinique du Petit Colmoulins
Harfleur, 76700, France
Saint Omer - CHI
Helfaut, 62570, France
Jonzac - CH
Jonzac, 17500, France
Chartres - CH
Le Coudray, 28630, France
Centre Hospitalier - Pneumologie
Le Mans, 72000, France
CH
Longjumeau, France
APHM - Hôpital Sainte Marguerite
Marseille, 13000, France
Marseille - CRLCC
Marseille, France
Maubeuge - Polyclinique du Parc
Maubeuge, 59600, France
Meaux - CH
Meaux, 77100, France
Metz - CHR
Metz, 57000, France
Mont de Marsan - CH
Mont-de-Marsan, 40000, France
Montpellier - CHRU
Montpellier, 34295, France
Mulhouse - CH
Mulhouse, 68000, France
Neuilly - Hôpital Américain de Paris
Neuilly, 92200, France
Nevers - CH
Nevers, 58033, France
Nice - CAC
Nice, 06000, France
Orléans - CH
Orléans, 45000, France
APHP - Saint-Antoine - pneumologie
Paris, 75012, France
APHP - Hopital Tenon - Pneumologie
Paris, 75020, France
Pau - CH
Pau, 64046, France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, 69495, France
Reims - CHU
Reims, 51092, France
Reims - CRLCC
Reims, France
Rouen - CHU
Rouen, 76000, France
Saint Brieuc - CHG
Saint-Brieuc, 22000, France
Saint Nazaire - Centre Etienne Dolet
Saint-Nazaire, 44600, France
Saint Priest en Jarez - ICL
Saint-Priest-en-Jarez, 42270, France
Saint Quentin - CH
Saint-Quentin, 02100, France
Saverne - CH
Saverne, France
Senlis - CH
Senlis, 60300, France
Nouvel Hopital Civil - Pneumologie
Strasbourg, 63000, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Thonon les bains
Thonon-les-Bains, 74200, France
Toulon - HIA
Toulon, 83000, France
CHU Toulouse - Pneumologie
Toulouse, France
Toulouse - Clinique Pasteur
Toulouse, France
Tours - CHU
Tours, 37000, France
Nancy - CHU
Vandœuvre-lès-Nancy, 54500, France
Verdun - CHG
Verdun, France
Vesoul - CHI
Vesoul, 70000, France
Institut Gustave Roussy
Villejuif, 94800, France
Related Publications (5)
Pujol JL, Breton JL, Gervais R, Tanguy ML, Quoix E, David P, Janicot H, Westeel V, Gameroff S, Geneve J, Maraninchi D. Phase III double-blind, placebo-controlled study of thalidomide in extensive-disease small-cell lung cancer after response to chemotherapy: an intergroup study FNCLCC cleo04 IFCT 00-01. J Clin Oncol. 2007 Sep 1;25(25):3945-51. doi: 10.1200/JCO.2007.11.8109.
PMID: 17761978BACKGROUNDPujol JL, Daures JP, Riviere A, Quoix E, Westeel V, Quantin X, Breton JL, Lemarie E, Poudenx M, Milleron B, Moro D, Debieuvre D, Le Chevalier T. Etoposide plus cisplatin with or without the combination of 4'-epidoxorubicin plus cyclophosphamide in treatment of extensive small-cell lung cancer: a French Federation of Cancer Institutes multicenter phase III randomized study. J Natl Cancer Inst. 2001 Feb 21;93(4):300-8. doi: 10.1093/jnci/93.4.300.
PMID: 11181777BACKGROUNDHorn L, Dahlberg SE, Sandler AB, Dowlati A, Moore DF, Murren JR, Schiller JH. Phase II study of cisplatin plus etoposide and bevacizumab for previously untreated, extensive-stage small-cell lung cancer: Eastern Cooperative Oncology Group Study E3501. J Clin Oncol. 2009 Dec 10;27(35):6006-11. doi: 10.1200/JCO.2009.23.7545. Epub 2009 Oct 13.
PMID: 19826110BACKGROUNDPujol JL, Lavole A, Quoix E, Molinier O, Souquet PJ, Barlesi F, Le Caer H, Moro-Sibilot D, Fournel P, Oster JP, Chatellain P, Barre P, Jeannin G, Mourlanette P, Derollez M, Herman D, Renault A, Dayen C, Lamy PJ, Langlais A, Morin F, Zalcman G; French Cooperative Thoracic Intergroup (IFCT). Randomized phase II-III study of bevacizumab in combination with chemotherapy in previously untreated extensive small-cell lung cancer: results from the IFCT-0802 trialdagger. Ann Oncol. 2015 May;26(5):908-914. doi: 10.1093/annonc/mdv065. Epub 2015 Feb 16.
PMID: 25688059RESULTNegre E, Coffy A, Langlais A, Daures JP, Lavole A, Quoix E, Molinier O, Greillier L, Audigier-Valette C, Moro-Sibilot D, Westeel V, Morin F, Roch B, Pujol JL. Development and Validation of a Simplified Prognostic Score in SCLC. JTO Clin Res Rep. 2020 Feb 12;1(1):100016. doi: 10.1016/j.jtocrr.2020.100016. eCollection 2020 Mar.
PMID: 34589918DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Louis PUJOL, Pr
CHRU Montpellier
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 2, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2013
Last Updated
March 10, 2016
Record last verified: 2016-03