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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Shirish Gadgeel, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT01665443
First received: August 12, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

This phase II trial studies how well giving bevacizumab together with docetaxel works in treating older patients with stage III-IV non-small cell lung cancer. 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, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel may kill more tumor cells


Condition Intervention Phase
Adenocarcinoma of the Lung
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Biological: bevacizumab
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Avastin 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:
  • Objective response [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Descriptive statistics (point and exact 90% confidence interval estimates) will be generated.


Secondary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every 2-4 courses and at 4 weeks after completion of treatment ] [ Designated as safety issue: No ]
  • Toxicity rate [ Time Frame: At days 1 and 15 of each course for the first 4 courses, and then once every course ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: January 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (monoclonal antibody and chemotherapy)
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Drug: docetaxel
Given IV
Other Names:
  • RP 56976
  • Taxotere
  • TXT

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the proportion of elderly (>= 75 years) patients with advanced non-small cell lung cancer (NSCLC) surviving for at least 6 months when treated with combination of Avastin (bevacizumab) and weekly docetaxel.

SECONDARY OBJECTIVES:

I. To assess the progression free survival and overall survival. II. To determine the response rate with this regimen. III. To assess the toxicity of this regimen.

OUTLINE:

Patients receive bevacizumab intravenously (IV) over 30-90 minutes on days 1 and 15 and docetaxel IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 4 weeks and then up to 6 months.

  Eligibility

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

Inclusion Criteria

  • Patients, who are ≥ 75years, must have histologically or cytologically proven stage III/IV NSCLC, excluding squamous cell histology (patients with tumors with mixed cell histologies will be allowed if the squamous cell component is less than 50%) and who have never received chemotherapy for advanced NSCLC. Patients with squamous cell histology will be allowed if the primary tumor has been resected. Patients who have received adjuvant therapy, which did not include docetaxel or avastin, will be allowed if the adjuvant therapy was completed more than 1 year prior to the detection of recurrent NSCLC. Stage III patients will be eligible if they are not considered candidates for concurrent chemotherapy and radiation.
  • Patients may have measurable or evaluable disease.
  • Life expectancy of greater than 12 weeks.
  • ECOG performance status < 2 (Karnofsky > 60%).
  • Patients should undergo a brain MRI/CT scan within 4 weeks of study enrollment to evaluate for brain metastases.
  • Patients must have adequate organ and marrow function as defined below:

    • leukocytes > 3,000/mcL
    • absolute neutrophil count > 1,500/mcL
    • platelets > 100,000/mcL
    • total bilirubin < 1.5 X institutional upper limit of normal
    • AST(SGOT)/ALT(SGPT)< 2.5 X institutional upper limit of normal < 5 X institutional upper limit of normal if patients has liver metastases
    • creatinine < 1.5 X of normal institutional limits
    • Cardiac function - MUGA scan or Echocardiogram- Left ventricular function should be > institutional normal limit
  • Ability to understand and the willingness to sign a written informed consent document.
  • Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State University

Exclusion Criteria

  • Patients with evidence of cavitation in the tumor.
  • Patients with mixed histology will be allowed as long as the biopsy has less than 50% squamous cell histology.
  • Patients who have had radiotherapy within 7 days of starting therapy on this study. Patients should have recovered to grade 1 or less from any adverse effects of the radiation.
  • Patients with active brain metastases should be excluded. Patients with treated brain metastases will be allowed on the trial
  • Patients cannot start on therapy on this trial < 7 days after completion of treatment for the brain metastases. Patient can be registered on the trial within 7 days of completing treatment for brain metastases.
  • Brain scan should not have evidence of hemorrhage in the brain
  • Patients should have stable or declining dose of steroids.
  • Patients with craniotomy will not be able to start therapy for at least 3 months after craniotomy.
  • Patients with resting blood pressure (BP) consistently > 140/90mm of Hg. Patients whose BP is controlled (< 140 mm of Hg systolic and < 90mm of Hg diastolic) after adjusting, starting or increasing the medications will be eligible.
  • Patients with Urine Protein: Creatinine ratio > 1.0 at screening and/or Patients with > 1+ protein in the urine. Patients with urine protein > 1+ can be eligible if they undergo 24 hours urine collection and the urine protein is ≤ 1gin 24 hours.
  • Patients with significant hemorrhage (> 30 mL bleeding/episode in previous 3 months) or hemoptysis that is > 5mL fresh blood in one episode in the previous 3 months.
  • Evidence of bleeding diathesis or coagulopathy.
  • Current or recent (within 10 days of enrollment) use of aspirin ≥ 325 mg/day or chronic use of Non-Steroidal Anti-inflammatory Drugs (NSAIDS).
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of therapy or anticipation of need for major surgical procedure during the course of the study. Core biopsy or other minor procedure, excluding placement of a vascular access device within 7 days prior to start of therapy.
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Patients may not be receiving any other investigational agents nor have participated in a trial involving an investigational agent within 30 days of starting therapy on this trial. Patient should have recovered to grade 1 or less from any adverse effects from any prior therapy excluding alopecia.
  • Patients with 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 that the other malignancy will not impact patient's overall survival.
  • Patients with history of myocardial infarction or cerebrovascular episode within 1 year of starting therapy on this study.
  • Significant vascular disease such as aortic aneurysm, aortic dissection and symptomatic peripheral vascular disease.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, NYHA class II or greater congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known hypersensitivity to any component of Avastin.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665443

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Genentech
Investigators
Principal Investigator: Shirish Gadgeel Barbara Ann Karmanos Cancer Institute
  More Information

No publications provided

Responsible Party: Shirish Gadgeel, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT01665443     History of Changes
Other Study ID Numbers: 2007-053, NCI-2011-00668
Study First Received: August 12, 2012
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antibodies
Antibodies, Monoclonal
Docetaxel
Bevacizumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014