Bevacizumab, Pemetrexed Disodium, and Cisplatin or Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Non-Small Cell Lung Cancer. A Multicenter Phase II Trial Including Biopsy at Progression (BIO-PRO Trial).

Sponsor
Swiss Cancer Institute
Study ID
NCT01116219
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab, erlotinib — BIOLOGICAL
    * Bevacizumab 7.5 mg/kg i.v. every 3 weeks and * Erlotinib 150 mg p.o. daily until progression.
  • bevacizumab, pemetrexed, cisplatin — DRUG
    Induction chemotherapy with * Bevacizumab 7.5 mg/kg i.v. and * Pemetrexed 500 mg/m2 i.v. and * Cisplatin\* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression. Followed by maintenance therapy in patients without disease progression with * Bevacizumab 7.5 mg/kg i.v. and * Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.

Study Details

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether bevacizumab given together with pemetrexed disodium and cisplatin is more effective than erlotinib hydrochloride given together with bevacizumab in treating patients with non-small cell lung cancer. PURPOSE: This phase II trial is studying giving bevacizumab together with pemetrexed disodium and cisplatin to see how well it works compared with giving erlotinib hydrochloride together with bevacizumab in treating patients with stage IV non-small cell lung cancer.

Key Dates

First listed
May 4, 2010
Start date
Jun 30, 2010
Status verified
May 2019
Primary completion
Jul 31, 2014
Completion
May 31, 2016

Study Design

Enrollment
149 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Stratum mut EGFR
    * Bevacizumab 7.5 mg/kg i.v. every 3 weeks and * Erlotinib 150 mg p.o. daily until progression.
  • Active Comparator: Stratum wtEGFR
    Cohort 1: Induction chemotherapy with * Bevacizumab 7.5 mg/kg i.v. and * Pemetrexed 500 mg/m2 i.v. and * Cisplatin\* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression. Followed by maintenance therapy in patients without disease progression with * Bevacizumab 7.5 mg/kg i.v. and * Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression. Cohort 2: Induction chemotherapy with * Pemetrexed 500 mg/m2 i.v. and * Cisplatin\* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression. Followed by maintenance therapy in patients without disease progression with o Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression.

Primary Outcome Measure

Progression-free survival at 6 months in stratum wtEGFR cohort 1 [ Time Frame: at 6 months ]

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