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

Purpose

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.

Condition	Intervention	Phase
Non-small Cell Lung Cancer Metastatic Nonsquamous Nonsmall Cell Neoplasm of Lung	Drug: Cisplatin Drug: Bevacizumab Drug: Pemetrexed	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Pemetrexed Pemetrexed disodium Bevacizumab

U.S. FDA Resources

Further study details as provided by Intergroupe Francophone de Cancerologie Thoracique:

Primary Outcome Measures:

Feasibility [ Time Frame: After 3 cycles ] [ Designated as safety issue: Yes ]
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence

Secondary Outcome Measures:

Control rate after the 2nd sequence [ Time Frame: After 3 cycles ] [ Designated as safety issue: No ]
Response rate after the 1st sequence [ Time Frame: After 3 cycles ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: During Sequence 2 : at the beginning and after 3 cycles ] [ Designated as safety issue: No ]


Enrollment:	118
Study Start Date:	December 2012
Estimated Study Completion Date:	February 2016
Estimated Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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	Drug: Cisplatin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence Drug: Bevacizumab 7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence Drug: 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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705184

Locations


France
Avignon - Institut Sainte-Catherine
Avignon, France, 84918
Caen - Centre François Baclesse
Caen, France, 14000
Caen - CHU Côte de Nacre
Caen, France, 14000
Centre Hospitalier
Chauny, France
CH du Mans
Le Mans, France
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
Marseille, France
Mulhouse - CH
Mulhouse, France, 68000
Nantes - Centre René Gauducheau
Nantes, France, 44805
Hopital Tenon - Pneumologie
Paris, France, 75020
HCL - Lyon Sud (Pneumologie)
Pierre Bénite, France, 69495
Rennes - CHU
Rennes, France, 35033
Strasbourg - NHC
Strasbourg, France, 63000

Sponsors and Collaborators

Intergroupe Francophone de Cancerologie Thoracique

Investigators


Principal Investigator:	Jaafar BENNOUNA, MD	Centre René Gauducheau - Nantes

More Information

Additional Information:

IFCT website This link exits the ClinicalTrials.gov site

Publications:

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, André 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.

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.


Responsible Party:	Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier:	NCT01705184 History of Changes
Other Study ID Numbers:	IFCT-1102, 2012-002647-18
Study First Received:	October 5, 2012
Last Updated:	February 12, 2015
Health Authority:	France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:


Stop and go Non-small cell lung cancer Non-squamous Bevacizumab

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Bevacizumab Cisplatin Pemetrexed Angiogenesis Inhibitors	Angiogenesis Modulating Agents Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Enzyme Inhibitors Folic Acid Antagonists Growth Inhibitors Growth Substances Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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