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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lung Cancer

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

Phase: N/A

Status: Completed

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Christopher Azzoli, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center


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.

Clinical Details

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

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

Primary outcome: 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.

Secondary outcome:

To evaluate the safety of docetaxel + vinorelbine chemotherapy delivered to patients with completely resected NSCLC.

To conduct an exploratory analysis of serial measurement of circulating DNA in blood as a way to track the effects of adjuvant chemotherapy.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey 07920, United States

Memorial Sloan-Kettering Cancer Center @ Suffolk, Commack, New York 11725, United States

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States

Memorial Sloan-Kettering at Mercy Medical Center, Rockville Centre, New York, United States

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center, Sleepy Hollow, New York 10591, United States

Additional Information

Memorial Sloan-Kettering Cancer Center

Starting date: May 2008
Last updated: February 8, 2012

Page last updated: August 23, 2015

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