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

Primary Purpose

Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Cisplatin
Bevacizumab
Pemetrexed
Sponsored by
Intergroupe Francophone de Cancerologie Thoracique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer Metastatic focused on measuring Stop and go, Non-small cell lung cancer, Non-squamous, Bevacizumab, IFCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Avignon - Institut Sainte-Catherine
  • Caen - Centre François Baclesse
  • Caen - CHU Côte de Nacre
  • Centre Hospitalier
  • CH du Mans
  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
  • Mulhouse - CH
  • Nantes - Centre René Gauducheau
  • Hopital Tenon - Pneumologie
  • HCL - Lyon Sud (Pneumologie)
  • Rennes - CHU
  • Strasbourg - NHC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BUCiL

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility
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
Response rate after the 1st sequence
Overall survival
Quality of life

Full Information

First Posted
October 5, 2012
Last Updated
March 10, 2023
Sponsor
Intergroupe Francophone de Cancerologie Thoracique
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1. Study Identification

Unique Protocol Identification Number
NCT01705184
Brief Title
Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intergroupe Francophone de Cancerologie Thoracique

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BUCiL
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility
Description
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
Time Frame
After 3 cycles
Secondary Outcome Measure Information:
Title
Control rate after the 2nd sequence
Time Frame
After 3 cycles
Title
Response rate after the 1st sequence
Time Frame
After 3 cycles
Title
Overall survival
Time Frame
12 months
Title
Quality of life
Time Frame
During Sequence 2 : at the beginning and after 3 cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaafar BENNOUNA, MD
Organizational Affiliation
Centre René Gauducheau - Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avignon - Institut Sainte-Catherine
City
Avignon
ZIP/Postal Code
84918
Country
France
Facility Name
Caen - Centre François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Caen - CHU Côte de Nacre
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Hospitalier
City
Chauny
Country
France
Facility Name
CH du Mans
City
Le Mans
Country
France
Facility Name
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
City
Marseille
Country
France
Facility Name
Mulhouse - CH
City
Mulhouse
ZIP/Postal Code
68000
Country
France
Facility Name
Nantes - Centre René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Tenon - Pneumologie
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
HCL - Lyon Sud (Pneumologie)
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Rennes - CHU
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Strasbourg - NHC
City
Strasbourg
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16421419
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.
Results Reference
background
PubMed Identifier
22341744
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.
Results Reference
background
PubMed Identifier
19786657
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.
Results Reference
background
Links:
URL
http://www.ifct.fr
Description
IFCT website

Learn more about this trial

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

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