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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), 07-178

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan-Kettering at Basking Ridge
  • Memorial Sloan-Kettering Cancer Center @ Suffolk
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan-Kettering at Mercy Medical Center
  • Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

To Measure the Number of Cycles
Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2008
Last Updated
October 20, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00675597
Brief Title
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Sanofi

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), 07-178

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients with Resected Stage I-III Non-small Cell Lung Cancer
Intervention Type
Drug
Intervention Name(s)
Bevacizumab (Avastin), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine)
Intervention Description
Patients will be treated as follows: vinorelbine (45 mg/m2) + docetaxel (45 mg/m2) intravenously on day 1, followed by pegylated filgrastim 6mg subcutaneously on day 2, delivered every 2 weeks for 8 doses total. Patients who have already received one cycle of cisplatin-based adjuvant chemotherapy need only complete 3 cycles of vinorelbine+docetaxel for a total of 4 cycles of adjuvant chemotherapy. Patients who require post-operative radiation therapy (PORT) will begin PORT after completion of vinorelbine + docetaxel.
Primary Outcome Measure Information:
Title
To Measure the Number of Cycles
Description
Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Azzoli, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center @ Suffolk
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering at Mercy Medical Center
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
City
Sleepy Hollow
State/Province
New York
ZIP/Postal Code
10591
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center

Learn more about this trial

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

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