Cisplatin and Gemcitabine With or Without Bevacizumab in EGFR Wild-type Non-Small Cell Lung Cancer

Sponsor
Sichuan Cancer Hospital and Research Institute
Study ID
NCT01623102
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • cisplatin and gemcitabine combination with Bevacizumab — DRUG
    Patients receive gemcitabine and cisplatin chemotherapy combined with Bevacizumab every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, cisplatin 75mg/m2 d1, Bevacizumab 7.5 mg / kg every 21 days.
  • Gemcitabine combined with cisplatin chemotherapy — DRUG
    Patients receive gemcitabine combined with cisplatin chemotherapy every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, + cisplatin 75mg/m2 d1.

Study Details

Advanced non-small-cell lung cancer (NSCLC) patients without epidermal growth factor receptor (EGFR) mutations show a poor prognosis. Gemcitabine combined with cisplatin chemotherapy is an effective treatment measures for EGFR mutation-negative NSCLC patients, but the prognosis remains poor. Chemotherapy combined with targeted monoclonal antibody treatment may be better treatment options in these patients. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Bevacizumab blocks the ability of tumors to grow new blood vessels and spread. It is not yet known whether cisplatin and gemcitabine is more effective when given alone or with bevacizumab. This randomized trial studies how well giving cisplatin and gemcitabine alone or in combination with Bevacizumab (Avastin) works in treating patients with stage IIIB/IV non-squamous NSCLC without EGFR mutations.

Key Dates

First listed
Jun 19, 2012
Start date
Feb 28, 2013
Status verified
Feb 2013
Primary completion
Aug 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: bevacizumab plus chemotherapy
    Patients in the experimental arm receive cisplatin and gemcitabine combination with Bevacizumab. GP chemotherapy (gemcitabine 1250mg/m2 IV D1 and D8 plus cisplatin 75mg/m2 IV D1, every 21-day cycle) plus bevacizumab (7.5 mg/kg IV on D1 of every 21-day cycle).
  • Active Comparator: Arm II: chemotherapy
    Patients receive gemcitabine combined with cisplatin chemotherapy((gemcitabine 1250mg/m2 IV D1 and D8 plus cisplatin 75mg/m2 IV D1, every 21-day cycle) ) every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

disease-free time to progression [ Time Frame: 6 week ]

Central Contacts

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