Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.
NCT ID: NCT01705184
Last Updated: 2023-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2012-12-31
2017-10-31
Brief Summary
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In colo-rectal metastatic cancer, it was demonstrated that the first-line of treatment could be administered according to a stop and go strategy respecting therapeutic breaks between sequences of identical treatment. During these therapeutic breaks, a treatment of maintenance is possibly better than an absence of treatment. These plans benefit to the patients in terms of efficiency but also in terms of toxicity, in particular neurological.
The question is to know if this strategy is feasible in lung cancer.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BUCiL
Sequence 1 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab if disease control. If progression --\> Sequence 2
Sequence 2 : 3 cycles of cisplatin-pemetrexed-bevacizumab, then maintenance by bevacizumab-pemetrexed if disease control
Cisplatin
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
Bevacizumab
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
Pemetrexed
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
Interventions
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Cisplatin
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
Bevacizumab
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
Pemetrexed
500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
Eligibility Criteria
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Inclusion Criteria
* Stage IV NSCLC. Patient with cerebral metastasis are eligible if the metastasis is asymptomatic.
* Measurable disease (recist criteria)
* Age ≥18 years
* PS0 or 1
Exclusion Criteria
* History of malignant tumour excepted cervical and basocellular cancer and cancer cured for at least 5 years.
* Tumor invaded the big vessels or the proximal visible in TDM.
* History of adjuvant or neoadjuvant chemotherapy
18 Years
ALL
No
Sponsors
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Intergroupe Francophone de Cancerologie Thoracique
OTHER
Responsible Party
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Principal Investigators
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Jaafar BENNOUNA, MD
Role: PRINCIPAL_INVESTIGATOR
Centre René Gauducheau - Nantes
Locations
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Avignon - Institut Sainte-Catherine
Avignon, , France
Caen - Centre François Baclesse
Caen, , France
Caen - CHU Côte de Nacre
Caen, , France
Centre Hospitalier
Chauny, , France
CH du Mans
Le Mans, , France
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
Marseille, , France
Mulhouse - CH
Mulhouse, , France
Nantes - Centre René Gauducheau
Nantes, , France
Hopital Tenon - Pneumologie
Paris, , France
HCL - Lyon Sud (Pneumologie)
Pierre-Bénite, , France
Rennes - CHU
Rennes, , France
Strasbourg - NHC
Strasbourg, , France
Countries
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References
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Tournigand C, Cervantes A, Figer A, Lledo G, Flesch M, Buyse M, Mineur L, Carola E, Etienne PL, Rivera F, Chirivella I, Perez-Staub N, Louvet C, Andre T, Tabah-Fisch I, de Gramont A. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study. J Clin Oncol. 2006 Jan 20;24(3):394-400. doi: 10.1200/JCO.2005.03.0106.
Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.
Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, Andre T, Bennamoun M, Mabro M, Artru P, Carola E, Flesch M, Dupuis O, Colin P, Larsen AK, Afchain P, Tournigand C, Louvet C, de Gramont A. Can chemotherapy be discontinued in unresectable metastatic colorectal cancer? The GERCOR OPTIMOX2 Study. J Clin Oncol. 2009 Dec 1;27(34):5727-33. doi: 10.1200/JCO.2009.23.4344. Epub 2009 Sep 28.
Related Links
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IFCT website
Other Identifiers
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2012-002647-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IFCT-1102
Identifier Type: -
Identifier Source: org_study_id
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