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Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541099
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : August 21, 2014
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 8, 2007
Results First Submitted Date  ICMJE August 5, 2014
Results First Posted Date  ICMJE August 21, 2014
Last Update Posted Date March 27, 2019
Study Start Date  ICMJE January 2008
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2012)
Survival [ Time Frame: 6 months when treated with combination of Avastin and weekly docetaxel ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
Objective response
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Progression-free Survival [ Time Frame: 6 months when treated with combination of Avastin and weekly docetaxel ]
    Progression-free survival in months via the Kaplan-Meier method
  • Overall Survival [ Time Frame: 4 weeks after removal from study or until death ]
    Overall survival using Kaplan-Meier method.
  • Response Rate [ Time Frame: Every 8 weeks ]
  • Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: 1st and 2nd week of each 21 day cycle, up to six cycles. ]
    Toxicity: using the highest grade of each toxicity experienced by each patient according to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2007)
  • Progression-free survival at 6 months
  • Overall Survival
  • Response Rate
  • Toxicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official Title  ICMJE Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel works in treating older patients with stage III or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES:

Primary

  • To determine the proportion of elderly (≥ 75 years of age) patients with stage III or IV non-small cell lung cancer surviving for at least 6 months when treated with a combination of bevacizumab and weekly docetaxel.

Secondary

  • To assess the progression-free and overall survival of patients treated with this regimen.
  • To determine the response rate in patients treated with this regimen.
  • To assess the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV on days 1, 8, and 15. Treatment may repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Biological: bevacizumab
    Avastin 10.0 mg/kg on days 1 and 15
    Other Name: Avastin
  • Drug: docetaxel
    Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15
    Other Name: TAXOTERE®
Study Arms  ICMJE Experimental: Avastin & Docetaxel
Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15
Interventions:
  • Biological: bevacizumab
  • Drug: docetaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
11
Original Enrollment  ICMJE
 (submitted: October 5, 2007)
18
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically or cytologically confirmed non-small cell lung cancer

    • Stage III or IV disease

      • Stage III disease allowed, provided the patient is not a candidate for concurrent chemotherapy and radiotherapy
    • Mixed histology allowed, provided the biopsy has less than 50% squamous cell histology
  • Measurable or evaluable disease

Exclusion criteria:

  • Squamous cell histology
  • Evidence of cavitation in the tumor
  • Tumors in close proximity to major blood vessels
  • No active, untreated brain metastases

    • More than 7 days since prior treatment for brain metastases AND no evidence of hemorrhage in the lesion
    • Stable or declining dose of steroids allowed

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Life expectancy > 12 weeks
  • Leukocytes ≥ 3,000/μL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelet count ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN (< 5 times ULN if patients has liver metastases)
  • Creatinine ≤ 1.5 times normal
  • Left ventricular function ≥ normal by MUGA scan or ECHO
  • Urine protein:creatinine ratio ≤ 1.0 AND/OR urine protein ≤ 1+ by dipstick analysis OR protein ≤ 1 g/24-hour urine collection
  • Fertile patients must use effective contraception and women should avoid breastfeeding

Exclusion criteria:

  • Resting blood pressure (BP) consistently > 140/90 mm Hg

    • Patients whose BP is controlled (≤ 140 mm Hg systolic and ≤ 90 mm Hg diastolic) after adjusting, starting, or increasing the medications are eligible
  • Significant hemorrhage (i.e., > 30 mL bleeding/episode ) or hemoptysis (i.e., > 5 mL fresh blood in one episode) in the previous 3 months
  • Evidence of bleeding diathesis or coagulopathy
  • Significant traumatic injury within the past 28 days
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • History of other active malignancies

    • If patient has other cancers such as PSA only (without clinical or radiographic evidence) prostate cancer, the patient can still be considered for this protocol if, in the clinical judgment of the treating physician, NSCLC is the most important malignancy and the other malignancy will not impact patient's overall survival
  • Myocardial infarction or cerebrovascular episode within the past year
  • Serious nonhealing wound or ulcer
  • Significant vascular disease such as aortic aneurysm, aortic dissection, or symptomatic peripheral vascular disease
  • Uncontrolled concurrent illness that would limit compliance with study requirements including, but not limited to, the following:

    • Ongoing or active infection
    • New York Heart Association class II-IV congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations
  • Known hypersensitivity to any component of bevacizumab

PRIOR CONCURRENT THERAPY:

  • More than 7 days since prior radiotherapy and recovered
  • No concurrent full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular-weight heparin)
  • More than 10 days since prior and no concurrent aspirin ≥ 325 mg/day or chronic use of nonsteroidal anti-inflammatory drugs
  • More than 28 days since prior and no concurrent major surgical procedure or open biopsy
  • More than 7 days since prior core biopsy or other minor procedure, excluding placement of a vascular access device
  • No other concurrent investigational agents, commercial agents, or therapies
  • More than 30 days since prior participation in a trial involving an investigational agent
  • No prior chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years to 120 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00541099
Other Study ID Numbers  ICMJE CDR0000555019
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2007-053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shirish M. Gadgeel, Barbara Ann Karmanos Cancer Institute
Study Sponsor  ICMJE Barbara Ann Karmanos Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP