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

Purpose

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.

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

MedlinePlus related topics:

Cancer Lung Cancer

Drug Information available for:

Filgrastim Docetaxel Vinorelbine Vinorelbine tartrate Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety of docetaxel + vinorelbine chemotherapy delivered to patients with completely resected NSCLC. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]
To conduct an exploratory analysis of serial measurement of circulating DNA in blood as a way to track the effects of adjuvant chemotherapy. [ Time Frame: conclusion of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	42
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental

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

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

Patients who are eligible to receive bevacizumab will be treated as follows:

vinorelbine (45 mg/m2) + docetaxel (60 mg/m2) + bevacizumab (10 mg/kg) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total, followed by bevacizumab 15 mg/kg intravenously every 3 weeks for one year. Patients receiving bevacizumab who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel. Bevacizumab patients who are prescribed PORT must stop bevacizumab during PORT, then resume bevacizumab after completion of PORT.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 and Johns Hopkins.
Patients are eligible if they are unfit for cisplatin-based adjuvant chemotherapy based on specified clinical criteria (listed below), or have a tumor which stains positive for ERCC1.
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.
> than or equal to 28 days status post lung surgery
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675597

Contacts


Contact: Christopher Azzoli, MD		azzolic@mskcc.org

Contact: Bernard Park, MD		parkb@mskcc.org

Locations


United States, New York
	Memorial Sloan Kettering Cancer Center	Recruiting
	New York, New York, United States, 10065
	Contact: Christopher Azzoli, MD azzolic@mskcc.org
	Contact: Bernard Park, MD parkb@mskcc.org
	Principal Investigator: Christopher Azzoli, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Johns Hopkins University

Sanofi-Aventis

Investigators


Principal Investigator:	Christopher Azzoli, MD	Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan Kettering Cancer Center ( Christopher Azzoli, MD )
Study ID Numbers:	07-178
First Received:	May 7, 2008
Last Updated:	October 1, 2008
ClinicalTrials.gov Identifier:	NCT00675597
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Bevacizumab (Avastin)

Taxotere (Docetaxel)

Vinorelbine Tartrate (Navelbine)

Study placed in the following topic categories:

Docetaxel

Thoracic Neoplasms

Non-small cell lung cancer

Vinorelbine

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Vinblastine

Bevacizumab

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Mitosis Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Therapeutic Uses

Tubulin Modulators

Growth Inhibitors

Angiogenesis Modulating Agents

Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Johns Hopkins University Sanofi-Aventis
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00675597