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NCT01705184 Clinical Trial

Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.

Non-small Cell Lung Cancer Metastatic Clinical Trial

— BUCiL  

Official title:
Phase II Study Evaluating the Interest of the Re-introduction of Pemetrexed and Platinum (Cisplatin or Carboplatin) With Prolonged Angiogenic Blocking by Bevacizumab in Non Squamous Non Small Cell Lung Cancer of Advanced Stage.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01705184
Other study ID # IFCT-1102
Secondary ID 2012-002647-18
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2012
Est. completion date October 2017

Study information
Verified date March 2023
Source Intergroupe Francophone de Cancerologie Thoracique
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

At present, the treatment of non-squamous cell lung cancer is based on chemotherapy with platinum eventually associated with bevacizumab. A new treatment begins at progression. 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 2017
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Non squamous non small cell lung cancer histologically or cytologically confirmed with no EGFR mutation. - 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: - Mixed cancer small cells and non small cells or squamous lung cancer . EGFR mutated cancer - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
France 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

Sponsors (1)
Lead Sponsor Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence After 3 cycles
Secondary Control rate after the 2nd sequence After 3 cycles
Secondary Response rate after the 1st sequence After 3 cycles
Secondary Overall survival 12 months
Secondary Quality of life During Sequence 2 : at the beginning and after 3 cycles
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