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Small Cell Lung CancerPhase 2/3CPCNCT00930891

Bevacizumab in Extensive Small Cell Lung Cancer

A Phase 2/3 study testing Standard Chemotherapy (PCDE or PE), Experimental Treatment (PCDE or PE + bevacizumab) and Prerandomization Chemotherapy (PCDE or PE) in people with Small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 60 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Standard Chemotherapy (PCDE or PE), Experimental Treatment (PCDE or PE + bevacizumab) and Prerandomization Chemotherapy (PCDE or PE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
60 sitesFrance
Study dates
Sep 2009to Jul 2013
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 28Show fewer
  • 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
  • Medical history of abdominal fistula, trachea-oesophageal fistula, of another type with a severity rank of 4, gastrointestinal perforation or intraabdominal abscess during 6 month before inclusion
  • 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
  • Clinically significative cardiac disease: infarct or CVA during 6 month before inclusion, unstable angina, congestive cardiac failure level > II as defined by New York Heart Association (NYHA) or cardiac arrythmia needing a specific treatment which risk to interfere with the study, or uncontrolled arrythmia.
  • Known allergy or hypersensibility to monoclonal antibodies (bevacizumab), to chinese hamster ovary cells or to any humanized or recombinant antibody
  • Uncontrolled high blood pressure (systolic pressure > 150 mm Hg and/or diastolic pressure > 100 mm Hg), with or without hypotension treatment. Patients presenting an high blood pressure are eligibles if their treatment can decrease their blood pressure to the values required by the protocol.
  • Severe ongoing infectious disease or fever > 38.5°C or evidence of any other pathology, organic or neurologic functions deterioration, physical examination or laboratory result which cause suspicion of a disease which contra-indicate use of any studied treatment.
  • Woman with a positive pregnancy test or who has not made a pregnancy test (unless pregnancy risk can be excluded)
  • Lactating woman
  • Sexually active woman who don't use hormonal or mechanical contraceptive method or sexually active man who has a sexually active partner who don't want to use an effective contraceptive method during the course of the study and during the 6 months after last treatment administration
  • Patient who as already been included and treated in the present study
  • Patient who participate or who has participated in another study during 4 weeks before treatment administration
  • Patient who receive a previous antiangiogenic treatment (experimental or commercial : bevacizumab, thalidomide, CP-547632, sunitinib, sorafenib...)
  • Geographical or psychological condition which not allowed a good comprehension or compliance to protocol
  • Liberty deprived patient

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

France60 sites

  • Annemasse - CH

    Ambilly, 74100

  • Angers - CHU

    Angers, 49000

  • Armentières - CH

    Armentières

  • CHU Besancon - Pneumologie

    Besançon, 25000

  • Centre F. Baclesse

    Caen, 14000

  • CHU - Pneumologie

    Caen, 14000

  • Cahors - CH

    Cahors, 46000

  • Chalons-en-Champagne - CH

    Châlons-en-Champagne

  • Chauny - CH

    Chauny

  • Hôpital Percy-Armées - Pneumologie

    Clamart, 92140

  • Clermont Ferrand - CHU

    Clermont-Ferrand, 63000

  • Colmar - CH

    Colmar, 68000

  • CH - Compiègne

    Compiègne, 60300

  • Créteil - CHI

    Créteil, 94000

  • Dijon - CAC

    Dijon, 21000

  • Dijon - CHU

    Dijon, 63000

  • Draguignan - CH

    Draguignan, 83300

  • CHU Grenoble - pneumologie

    Grenoble, 38000

  • Harfleur - Clinique du Petit Colmoulins

    Harfleur, 76700

  • Saint Omer - CHI

    Helfaut, 62570

  • Jonzac - CH

    Jonzac, 17500

  • Chartres - CH

    Le Coudray, 28630

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • CH

    Longjumeau

  • APHM - Hôpital Sainte Marguerite

    Marseille, 13000

  • Marseille - CRLCC

    Marseille

  • Maubeuge - Polyclinique du Parc

    Maubeuge, 59600

  • Meaux - CH

    Meaux, 77100

  • Metz - CHR

    Metz, 57000

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Montpellier - CHRU

    Montpellier, 34295

  • Mulhouse - CH

    Mulhouse, 68000

  • Neuilly - Hôpital Américain de Paris

    Neuilly, 92200

  • Nevers - CH

    Nevers, 58033

  • Nice - CAC

    Nice, 06000

  • Orléans - CH

    Orléans, 45000

  • APHP - Saint-Antoine - pneumologie

    Paris, 75012

  • APHP - Hopital Tenon - Pneumologie

    Paris, 75020

  • Pau - CH

    Pau, 64046

  • HCL - Lyon Sud (Pneumologie)

    Pierre-Bénite, 69495

  • Reims - CHU

    Reims, 51092

  • Reims - CRLCC

    Reims

  • Rouen - CHU

    Rouen, 76000

  • Saint Brieuc - CHG

    Saint-Brieuc, 22000

  • Saint Nazaire - Centre Etienne Dolet

    Saint-Nazaire, 44600

  • Saint Priest en Jarez - ICL

    Saint-Priest-en-Jarez, 42270

  • Saint Quentin - CH

    Saint-Quentin, 02100

  • Saverne - CH

    Saverne

  • Senlis - CH

    Senlis, 60300

  • Nouvel Hopital Civil - Pneumologie

    Strasbourg, 63000

  • Suresnes - Hopital Foch

    Suresnes, 92151

  • Thonon les bains

    Thonon-les-Bains, 74200

  • Toulon - HIA

    Toulon, 83000

  • CHU Toulouse - Pneumologie

    Toulouse

  • Toulouse - Clinique Pasteur

    Toulouse

  • Tours - CHU

    Tours, 37000

  • Nancy - CHU

    Vandœuvre-lès-Nancy, 54500

  • Verdun - CHG

    Verdun

  • Vesoul - CHI

    Vesoul, 70000

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: 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)

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.

Being tested
Standard Chemotherapy (PCDE or PE), Experimental Treatment (PCDE or PE + bevacizumab), Prerandomization Chemotherapy (PCDE or PE)
Keywords
Extensive-Disease Small-Cell Lung Cancer
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard Chemotherapy (PCDE or PE)Drug

    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

  • Experimental Treatment (PCDE or PE + bevacizumab)Drug

    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

  • Prerandomization Chemotherapy (PCDE or PE)Drug

    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

Study groups in NCT00930891
Study groupRoleWhat they receive
Arm AActive comparator4 additional cycles of chemotherapy
Receives: Drug: Standard Chemotherapy (PCDE or PE); Drug: Prerandomization Chemotherapy (PCDE or PE)
Arm BExperimental4 additional cycles of chemotherapy + bevacizumab
Receives: Drug: Experimental Treatment (PCDE or PE + bevacizumab); Drug: Prerandomization Chemotherapy (PCDE or PE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (complete response + partial response)

    Measured: 6 weeks after randomization

Secondary outcomes (4)

  1. Progression-free survival

    Measured: 12 weeks

  2. Complete response length

    Measured: 12 weeks

  3. Quality of life

    Measured: 12 weeks

  4. Toxicities

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionJul 2012
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00930891
Sponsor's protocol ID
IFCT-0802
Other IDs
2009-010187-42, 2009
Acronym
CPC
Status last verified
Mar 2016
First submitted
1 Jul 2009
Last updated
10 Mar 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17761978

  • Pujol 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.

    PubMed 11181777

  • Horn 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.

    PubMed 19826110

  • Pujol 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.

    PubMed 25688059

  • Negre 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.

    PubMed 34589918

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Standard Chemotherapy (PCDE or PE), Experimental Treatment (PCDE or PE + bevacizumab) and Prerandomization Chemotherapy (PCDE or PE) in people with Small Cell Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 60 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (complete response + partial response) (time frame: 6 weeks after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00930891, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.

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