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

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

Tracking Information

• First Submitted Date: October 5, 2012
• First Posted Date: October 12, 2012
• Last Update Posted Date: May 13, 2019
• Study Start Date: December 2012
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01705184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• 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

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 *

• 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.
• Chibaudel B, Maindrault-Goebel F, Lledo G, Mineur L, André 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 11, 2014): 118
• Original Estimated Enrollment (submitted: October 11, 2012): 108
• Actual Study Completion Date: October 2017
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01705184
• Other Study ID Numbers: IFCT-1102; 2012-002647-18 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
• Study Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Collaborators: Not Provided

Investigators

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

• PRS Account: Intergroupe Francophone de Cancerologie Thoracique
• Verification Date: May 2019