Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Lung Cancer

Treatments

Drug: Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00675597

07-178

Details and patient eligibility

About

The purpose of this study is to determine whether a combination of the drugs docetaxel (Taxotere ® ), plus vinorelbine (Navelbine ® ), will result in fewer side effects than cisplatin chemotherapy, thereby improving delivery of chemotherapy in patients.

Another purpose of this study is to determine whether a third drug, bevacizumab (Avastin®), may be delivered safely with docetaxel plus vinorelbine in patients who are eligible to receive bevacizumab.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

> 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.