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

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ClinicalTrials.gov Identifier: NCT01705184
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility [ Time Frame: After 3 cycles ]
    Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence


Secondary Outcome Measures :
  1. Control rate after the 2nd sequence [ Time Frame: After 3 cycles ]
  2. Response rate after the 1st sequence [ Time Frame: After 3 cycles ]
  3. Overall survival [ Time Frame: 12 months ]
  4. Quality of life [ Time Frame: During Sequence 2 : at the beginning and after 3 cycles ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705184


Locations
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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
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Principal Investigator: Jaafar BENNOUNA, MD Centre René Gauducheau - Nantes
More Information
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Additional Information:

Publications:

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Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
ClinicalTrials.gov Identifier: NCT01705184    
Other Study ID Numbers: IFCT-1102
2012-002647-18 ( EudraCT Number )
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Keywords provided by Intergroupe Francophone de Cancerologie Thoracique:
Stop and go
Non-small cell lung cancer
Non-squamous
Bevacizumab
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Bevacizumab
Pemetrexed
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors