Mesothelioma Avastin Plus Pemetrexed-cisplatin Study

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT00651456
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Chemotherapy (Pemetrexed and Cisplatin) — DRUG
    * 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)
  • Standard Chemotherapy (Pemetrexed and Cisplatin) + Bevacizumab — DRUG
    * 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 Details

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.

Key Dates

First listed
Apr 2, 2008
Start date
Feb 29, 2008
Status verified
Mar 2023
Primary completion
Jan 31, 2015
Completion
Sep 30, 2016

Study Design

Enrollment
448 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Standard Chemotherapy
  • Experimental: 2
    Standard Chemotherapy + bevacizumab (Avastin)

Primary Outcome Measure

% of patients with controled disease (responder and stable patients) at 6 months [ Time Frame: 3-month ]

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