A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
- Patients must be at least 2 weeks status post complete (R0) surgical resection of
pathologically-proven NSCLC (stage IA-IIIB). Pathology review will be performed
independently at MSKCC.
- Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy
based on specified clinical criteria (listed below).
- Allergy to cisplatin
- Baseline hearing loss (defined as any subjective baseline hearing deficit, even if it
does not require a hearing aid or intervention, or interfere with activities of daily
life (CTCAE grade > or equal to 2)
- Baseline renal insufficiency (defined as a creatinine clearance of < than or equal to
60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's
age, weight (kg), and serum creatinine (mg/dl).
- Performance status 70% on the Karnofsky scale.
- Congestive heart failure with New York Heart Association functional classification >
or equal to II, characterized by fatigue, dyspnea or other symptoms which limit
activities of daily life.
- Patient refuses to take cisplatin.
- Age > than or equal 18
- Performance Status Karnofsky > than or equal to 70%
- Peripheral neuropathy must be < than grade 1
- Hematologic (minimal values)
- Absolute neutrophil count > than or equal to 1,500/mm3
- Hemoglobin > than or equal to 8.0 g/dl
- Platelet count > than or equal to 100,000/mm3 Hepatic
- Total Bilirubin < than or equal to 1.5 x ULN AST or ALT and Alkaline Phosphatase must
be within the range allowing for eligibility
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.
- Patients being considered for treatment with bevacizumab must have a urine protein:
creatinine (UPC) ratio < 1.0 at screening and an MRI of brain or CT brain with IV
contrast showing no evidence of brain metastases within 3 months of study entry
- > 16 weeks post-op
- Prior post-operative radiation
- > 1 cycle of prior adjuvant chemotherapy
- Patients with a history of severe hypersensitivity reaction to docetaxel or other
drugs formulated with polysorbate 80.
- Women who are pregnant, or breast-feeding.