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

March 10, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: After 3 cycles
Number of patients receiving 3 cycles of chemotherapy with full-dose platinum in the 2nd sequence
After 3 cycles

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-1102
  • 2012-002647-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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