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

NCT ID: NCT00541099

Last Updated: 2019-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: BIOLOGICAL

Avastin 10.0 mg/kg on days 1 and 15

docetaxel

Intervention Type: DRUG

Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Interventions

bevacizumab

Avastin 10.0 mg/kg on days 1 and 15

Intervention Type: BIOLOGICAL

docetaxel

Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15

Intervention Type: DRUG

Other Intervention Names

Avastin; TAXOTERE®

Eligibility Criteria

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

• 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

• 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:

• 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

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Shirish M. Gadgeel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirish M. Gadgeel, MD

Role: PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Locations

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Nevada Cancer Institute

Las Vegas, Nevada, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Related Links

http://cancer.gov/clinicaltrials

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-2007-053

Identifier Type: -

Identifier Source: secondary_id

CDR0000555019

Identifier Type: -

Identifier Source: org_study_id

NCT01665443

Identifier Type: -

Identifier Source: nct_alias