A Phase II Study of Combination Therapy of Carboplatin -Gemcitabine Plus Bevacizumab Beyond Progression in Patients With Locally Advanced and/or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Systemic Therapy
- Advanced stage NSCLC (IIIB with malignant pleural effusion or stage IV excluding
squamous cell histology, with measurable or evaluable disease.
- No prior systemic therapy for advanced NSCLC, prior therapy for early stage disease
with one regimen is acceptable if it was completed at least 6 months prior to study
- Palliative radiotherapy to painful bony metastases will be permitted prior to study
entry if completed prior to initiation of study treatment, and there are no residual
sequelae of therapy such as bone marrow suppression.
- Life expectancy of at least 3 months.
- ECOG Performance status 0-1 (see appendix 2)
- Age 18 or higher.
- Female patients with reproductive potential must have a negative serum pregnancy test
within 72 hours prior to start of study medication. All female patients of
childbearing potential, and all male patients, must agree to use a medically
acceptable method of contraception or agree to be abstinent throughout the treatment
period and for 3 months after discontinuation of treatment
- Patients must have normal organ and marrow function
- Prior systemic treatment for advanced NSCLC. One prior regimen (up to 4 cycles) of
neoadjuvant or adjuvant therapy for early stage disease will be allowed if completed
at least 6 months prior to study entry.
- Known brain metastases (in case of clinical signs or symptoms of brain metastases
radiological evaluation is mandatory).
- Prior treatment with bevacizumab or erlotinib.
- History of allergic reactions or sensitivity attributed to compounds of similar
chemical or biologic composition to bevacizumab or erlotinib.
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in any other experimental drug study.
- Concomitant chemotherapy, radiotherapy or investigational agents.
- Evidence of bleeding diathesis or coagulopathy.
- Use of full dose anti-coagulant agents.
- Pregnant (positive pregnancy test) or lactating women.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to start, anticipation of need for major surgical procedure during the course
of the study.
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
prior to start.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to start.
- Serious, non-healing wound, ulcer, or bone fracture.
- Lung carcinoma of squamous cell histology or any histology in close proximity to a
major vessel, or with significant cavitation as assessed by treating investigator in
consultation with an attending radiologist.
- History of hemoptysis (bright red blood of 2.5 ml or more).
- Significant co-morbidities including:
- No uncontrolled hypertension (systolic > 150 mmHg and/or diastolic > 100 mmHg)
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Clinically significant peripheral vascular disease
- Patients diagnosed with a trachea-oesophageal fistula
- Another active malignancy except for non-melanoma skin cancers in the last 5 years.
- Inability to comply with study and/or follow-up procedures.