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

18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To measure the number of cycles of docetaxel + vinorelbine which can be delivered to patients with completely resected NSCLC (up to 4) in order to estimate whether tolerability is better than reported for standard cisplatin + vinorelbine.

Outcome Time Frame:

conclusion of study

Safety Issue:


Principal Investigator

Christopher Azzoli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

February 2012

Related Keywords:

  • Lung Cancer
  • Bevacizumab (Avastin)
  • Taxotere (Docetaxel)
  • Vinorelbine Tartrate (Navelbine)
  • 07-178
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Memorial Sloan-Kettering at Basking Ridge Basking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York