Trial | NCT00150657  Report issue

Title

Study of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Lung Cancer
Phase II Trial of Carboplatin/Gemcitabine Plus Bevacizumab in Advanced Non-Small Cell Lung Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    45
this study is being done to find out if the combination of carboplatin and gemcitabine will be more effective in the the treatment of advanced lung cancer if bevacizumab, an agent that blocks tumor blood vessel formation, is added
the study will measure the time to progression of patients treated with the combination; we hope to show that the addition of bevacizumab improves the time to progression (increases the amount of time before the disease begins to worsen)
all patients receive all three drugs; there is no placebo
Patients with advanced (stage IV, and Stage IIIB with effusion) non-small cell lung cancer with non-squamous histology, good performance status, and adequate organ function are eligible.
Patients with brain metastases, squamous histology, or hemoptysis are excluded.
All patients must give informed consent.
Schema gemcitabine 1250 mg/M2 IV day 1,8 carboplatin AUC 5 IV day 1 bevacizumab 15 mg/kg IV day 1 repeated every 21 days for 6 cycles
Study Started
Nov 30
2004
Last Update
Nov 29
2005
Estimate

Drug bevacizumab

Drug carboplatin

Drug gemcitabine

Criteria 

Inclusion Criteria:

Histologically or cytologically proven non-small cell lung cancer, newly diagnosed or recurrent after previous surgery and/or radiation therapy
Stage IV disease or stage IIIB with a malignant pleural effusion
measurable or evaluable disease
Performance status 0 or 1 (ECOG)
adequate renal, hepatic, and bone marrow function
adequate recovery from previous surgery or radiotherapy
informed consent

Exclusion Criteria:

brain metastases
squamous (epidermoid) histology
hemoptysis
central airway disease
Pancoast tumors
previous chemotherapy or biologic therapy for lung cancer
prior malignancy within the previous 5 years except non-melanoma skin cancer or cervical CIS
pregnant or nursing women
No Results Posted