Mesothelioma Avastin Plus Pemetrexed-cisplatin Study (MAPS)

• ClinicalTrials.gov Identifier: NCT00651456
• Recruitment Status: Completed
• First Posted: April 2, 2008
• Last Update Posted: March 13, 2023
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Collaborators: University Hospital, Caen; Groupe Francais De Pneumo-Cancerologie
• Information provided by (Responsible Party): Intergroupe Francophone de Cancerologie Thoracique

Tracking Information

• First Submitted Date: March 29, 2008
• First Posted Date: April 2, 2008
• Last Update Posted Date: March 13, 2023
• Study Start Date: February 2008
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 1, 2008): % of patients with controled disease (responder and stable patients) at 6 months [ Time Frame: 3-month ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 13, 2016)

• Overall Survival [ Time Frame: month ]
• Number of participants with treatment-related adverse events as assessed by CTCAE v3.0 [ Time Frame: month ]

• Original Secondary Outcome Measures (submitted: April 1, 2008): Overall Survival [ Time Frame: month ]
• Current Other Pre-specified Outcome Measures (submitted: April 13, 2016): Medico-economic assessments of drugs (direct/indirect costs) [ Time Frame: 3-month ]
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mesothelioma Avastin Plus Pemetrexed-cisplatin Study
• Official Title: A Phase II-III Randomized Trial Pemetrexed-Cisplatin Chemotherapy With or Without Bevacizumab (Avastin), 15 mg/kg, for Malignant Pleural Mesothelioma (MPM)
• Brief Summary: Our hypothesis is that the addition of bevacizumab to the standard chemotherapy treatment of MPM will improve overall survival and quality of life beyond that achieved with chemotherapy alone.
• Detailed Description: A phase II trial associating the reference chemotherapy (pemetrexed plus cisplatin) with bevacizumab is needed to ensure that no specific toxicity is induced by this association, and that this triplet have interesting activity. As pleural mesothélioma is a rare tumor, a phase III trial, using the survival data from the phase II part study, will be able to include a sufficient number of patients, in a reasonable period of time, to answer the question of efficacy of the anti-angiogenic triplet, providing the efficacy outcomes could be considered as favorable, at the end of the phase II part of the study.
• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Mesothelioma

Intervention

• Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
  • Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation Day 1 (D1=D22, 6 cycles)
  • Cisplatin 75 mg/m² Day 1 (D1=D22, 6 cycles)
• Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab
  • Pemetrexed 500 mg/m² with previous Folic acid and vitamin B12 supplementation D1 (D1=D22, 6 cycles)
  • Cisplatin 75 mg/m2 D1 (D1=D22, 6 cycles)
  • Bevacizumab 15 mg/kg D1 (D1=D22, until progression)

Study Arms

• Active Comparator: 1
  Standard Chemotherapy
  Intervention: Drug: Standard Chemotherapy (Pemetrexed and Cisplatin)
• Experimental: 2
  Standard Chemotherapy + bevacizumab (Avastin)
  Intervention: Drug: Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab

Publications *

• Zalcman G, Mazieres J, Margery J, Greillier L, Audigier-Valette C, Moro-Sibilot D, Molinier O, Corre R, Monnet I, Gounant V, Riviere F, Janicot H, Gervais R, Locher C, Milleron B, Tran Q, Lebitasy MP, Morin F, Creveuil C, Parienti JJ, Scherpereel A; French Cooperative Thoracic Intergroup (IFCT). Bevacizumab for newly diagnosed pleural mesothelioma in the Mesothelioma Avastin Cisplatin Pemetrexed Study (MAPS): a randomised, controlled, open-label, phase 3 trial. Lancet. 2016 Apr 2;387(10026):1405-1414. doi: 10.1016/S0140-6736(15)01238-6. Epub 2015 Dec 21. Erratum In: Lancet. 2016 Apr 2;387(10026):e24.
• Brosseau S, Danel C, Scherpereel A, Mazieres J, Lantuejoul S, Margery J, Greillier L, Audigier-Valette C, Gounant V, Antoine M, Moro-Sibilot D, Rouquette I, Molinier O, Corre R, Monnet I, Langlais A, Morin F, Bergot E, Zalcman G, Levallet G. Shorter Survival in Malignant Pleural Mesothelioma Patients With High PD-L1 Expression Associated With Sarcomatoid or Biphasic Histology Subtype: A Series of 214 Cases From the Bio-MAPS Cohort. Clin Lung Cancer. 2019 Sep;20(5):e564-e575. doi: 10.1016/j.cllc.2019.04.010. Epub 2019 May 13.
• Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Biganzoli L, Muller B, Barbeaux A, Graas MP, Rabaglio M, Francis PA, Foukakis T, Pagani O, Graiff C, Vorobiof D, Maibach R, Di Leo A, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J; SOLE Investigators. Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 May;120(10):959-967. doi: 10.1038/s41416-019-0435-4. Epub 2019 Apr 10. Erratum In: Br J Cancer. 2020 Jan 16;:

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2016): 448
• Original Estimated Enrollment (submitted: April 1, 2008): 445
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Malignant, histologically proved, non resectable pleural Mesothelioma
• In case of pleural effusion, a talc pleurodesis, although not recommended, is allowed in accordance with current local practice, at the time of diagnostic thorascopy, with inclusion CT scan performed after pleurodesis.
• ECOG Performance status 0-2
• Mesothelioma with only pleural effusion without uni- or bidimensionally measurable disease will be eligible (adapted RECIST criteria)
• At least 18 years of age, less than 76 years of age
• Radiation therapy of thoracocentis tract (3 x 7Gy) performed before beginning medical study treatment, and the interval between thoracoscopic procedure and radiation will not exceed 28 days

Exclusion Criteria:

• Prior chemotherapy
• Brain metastasis
• History of cerebral vascular accident (CVA) or transient ischemic attack

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France
• Removed Location Countries: Belgium

Administrative Information

• NCT Number: NCT00651456
• Other Study ID Numbers: IFCT-GFPC-0701
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Intergroupe Francophone de Cancerologie Thoracique
• Original Responsible Party: Pr Gérad Zalcman, IFCT
• Current Study Sponsor: Intergroupe Francophone de Cancerologie Thoracique
• Original Study Sponsor: Same as current

Collaborators

• University Hospital, Caen
• Groupe Francais De Pneumo-Cancerologie

Investigators

• Study Director: Gilles Robinet, Dr; GFPC
• Study Director: Arnaud Scherpereel, Dr; Intergroupe Francophone de Cancerologie Thoracique

• PRS Account: Intergroupe Francophone de Cancerologie Thoracique
• Verification Date: March 2023