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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00541099
First received: October 5, 2007
Last updated: August 12, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Survival [ Time Frame: 6 months when treated with combination of Avastin and weekly docetaxel ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 6 months when treated with combination of Avastin and weekly docetaxel ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 4 weeks after removal from study or until death ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 1st and 2nd week of each 21 day cycle ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: January 2008
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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®

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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541099

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Shirish M. Gadgeel, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Shirish Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00541099     History of Changes
Obsolete Identifiers: NCT01665443
Other Study ID Numbers: CDR0000555019, P30CA022453, WSU-2007-053
Study First Received: October 5, 2007
Last Updated: August 12, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014