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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

Tracking Information
First Submitted Date  ICMJE October 5, 2012
First Posted Date  ICMJE October 12, 2012
Last Update Posted Date May 13, 2019
Study Start Date  ICMJE December 2012
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
Feasibility [ Time Frame: After 3 cycles ]
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01705184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • Control rate after the 2nd sequence [ Time Frame: After 3 cycles ]
  • Response rate after the 1st sequence [ Time Frame: After 3 cycles ]
  • Overall survival [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: During Sequence 2 : at the beginning and after 3 cycles ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Re-introduction of Pemetrexed and Cisplatin With Prolonged Angiogenic Blocking by Bevacizumab in Advanced Lung Cancer.
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer Metastatic
  • Nonsquamous Nonsmall Cell Neoplasm of Lung
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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

Interventions:
  • Drug: Cisplatin
  • Drug: Bevacizumab
  • Drug: Pemetrexed
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2014)
118
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2012)
108
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01705184
Other Study ID Numbers  ICMJE IFCT-1102
2012-002647-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intergroupe Francophone de Cancerologie Thoracique
Study Sponsor  ICMJE Intergroupe Francophone de Cancerologie Thoracique
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaafar BENNOUNA, MD Centre René Gauducheau - Nantes
PRS Account Intergroupe Francophone de Cancerologie Thoracique
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP