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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).

NCT01116219 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2019-05-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

bevacizumab, erlotinib

* Bevacizumab 7.5 mg/kg i.v. every 3 weeks and * Erlotinib 150 mg p.o. daily until progression.

DRUG

bevacizumab, pemetrexed, cisplatin

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.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Oliver Gautschi, MD · Luzerner Kantonsspital

  • Adrian Ochsenbein, MD · Insel Gruppe AG, University Hospital Bern

  • Nicolas Mach, MD · Hopital Cantonal Universitaire de Geneve HUG

  • Sacha Rothschild, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-07-31
Completion
2016-05-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116219 on ClinicalTrials.gov