Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

11

Study ID:

NCT00541099

Recruitment Status:

Completed

Sponsor:

Barbara Ann Karmanos Cancer Institute

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There are 3 Locations for this study

See Locations Near You

Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Nevada Cancer Institute
Las Vegas Nevada, 89135, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

11

Study ID:

NCT00541099

Recruitment Status:

Completed

Sponsor:


Barbara Ann Karmanos Cancer Institute

How clear is this clinincal trial information?

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