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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:May 2008
End Date:February 2012

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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

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.


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.
We found this trial at
5
sites
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Basking Ridge, New Jersey 07920
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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1000 N Village Ave
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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Rockville Centre, NY
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701 N Broadway
Sleepy Hollow, New York 10591
(914) 366-3000
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Memorial Sloan Kettering Cancer Center Sleepy...
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Sleepy Hollow, NY
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