Clinical trial NCT00541099: Bevacizumab and Docetaxel in Treating Older Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
Official title: Evaluation of Bevacizumab and Weekly Docetaxel in Elderly (≥ 75 Years) Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-10-08
Enrollment: 11
Sex: ALL
Minimum age (years): 75
Maximum age (years): 120
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Survival
timeFrame: 6 months when treated with combination of Avastin and weekly docetaxel
Secondary outcomes:
measure: Progression-free Survival
timeFrame: 6 months when treated with combination of Avastin and weekly docetaxel
measure: Overall Survival
timeFrame: 4 weeks after removal from study or until death
measure: Response Rate
timeFrame: Every 8 weeks
measure: Toxicity According to NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
timeFrame: 1st and 2nd week of each 21 day cycle, up to six cycles.
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Shirish M. Gadgeel, MD
role: PRINCIPAL_INVESTIGATOR
References: