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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: Sanofi
• Treatments: Bevacizumab; Docetaxel; Vinblastine; Vinorelbine

Criteria

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.