Clinical trial NCT01705184: Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic
Nonsquamous Nonsmall Cell Neoplasm of Lung
Keywords: Stop and go
Non-small cell lung cancer
Non-squamous
Bevacizumab
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2012-10-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: After 3 cycles
Secondary outcomes:
measure: Control rate after the 2nd sequence
timeFrame: After 3 cycles
measure: Response rate after the 1st sequence
timeFrame: After 3 cycles
measure: Overall survival
timeFrame: 12 months
measure: Quality of life
timeFrame: During Sequence 2 : at the beginning and after 3 cycles
Other outcomes:
Locations:
city: Avignon
country: France
facility: Avignon - Institut Sainte-Catherine
city: Caen
country: France
facility: Caen - Centre François Baclesse
city: Caen
country: France
facility: Caen - CHU Côte de Nacre
city: Chauny
country: France
facility: Centre Hospitalier
city: Le Mans
country: France
facility: CH du Mans
city: Marseille
country: France
facility: Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
city: Mulhouse
country: France
facility: Mulhouse - CH
city: Nantes
country: France
facility: Nantes - Centre René Gauducheau
city: Paris
country: France
facility: Hopital Tenon - Pneumologie
city: Pierre Bénite
country: France
facility: HCL - Lyon Sud (Pneumologie)
city: Rennes
country: France
facility: Rennes - CHU
city: Strasbourg
country: France
facility: Strasbourg - NHC
Study officials:
affiliation: Centre René Gauducheau - Nantes
name: Jaafar BENNOUNA, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.