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Pemetrexed Disodium and Bevac...

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

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-04-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.

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Detailed Description

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OBJECTIVES:

Primary

* Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer.

Secondary

* Determine the tumor response rate in these patients.
* Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients.
* Determine the toxicity profile of this drug regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Conditions

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Lung Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pemetrexed + bevacizumab

Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

Group Type EXPERIMENTAL

bevacizumab

Intervention Type BIOLOGICAL

pemetrexed disodium

Intervention Type DRUG

Interventions

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bevacizumab

Intervention Type BIOLOGICAL

pemetrexed disodium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No seizure disorder
* No clinically significant infection
* No other second primary malignancy within the past 5 years except carcinoma in situ of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6) localized prostate cancer
* No hypertension or labile hypertension
* No history of poor compliance with antihypertensive medications
* No angina pectoris
* No congestive heart failure within the past 3 months unless ejection fraction \> 40%
* No myocardial infarction within the past 6 months
* No cardiac arrhythmia
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No active or recent history of hemoptysis

* Hemoptysis resolved \> 2 weeks ago with measures such as palliative radiation therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is acceptable
* No diabetes
* No prior serious, non-healing wounds, ulcers, or bone fractures
* No history of stroke within the past 6 months
* No history of abdominal fistula or gastrointestinal perforation
* No intra-abdominal abscess within the past 6 months
* Not at greater than average risk of bleeding
* No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

* No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after pemetrexed disodium treatment
* No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)
* No immunotherapy or biologic therapy within the past 2 weeks
* No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks

* The site of previous radiotherapy should have evidence of progressive disease if it is the only site of disease
* No prior post pelvic radiation
* No prior use of pemetrexed disodium
* No prior radiation to \> 25% of the marrow cavity
* No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks
* No minor surgery within the past 2 weeks except insertion of a vascular access device
* No concurrent major surgery
* No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational within the past 4 weeks
* No concurrent use of Hypericum perforatum (St. John's wort)
* No concurrent anticoagulant use

* Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex A. Adjei, MD, PhD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

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Providence Cancer Center

Anchorage, Alaska, United States

Site Status

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Eden Medical Center

Castro Valley, California, United States

Site Status

Saint Rose Hospital

Hayward, California, United States

Site Status

Highland General Hospital at St. George's University School of Medicine

Oakland, California, United States

Site Status

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status

CCOP - Bay Area Tumor Institute

Oakland, California, United States

Site Status

Valley Care Medical Center

Pleasanton, California, United States

Site Status

Doctors Medical Center - San Pablo Campus

San Pablo, California, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital Cancer Center

Atlanta, Georgia, United States

Site Status

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, United States

Site Status

CCOP - Atlanta Regional

Atlanta, Georgia, United States

Site Status

WellStar Cobb Hospital

Austell, Georgia, United States

Site Status

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Kennestone Cancer Center at Wellstar Kennestone Hospital

Marietta, Georgia, United States

Site Status

Southern Regional Medical Center

Riverdale, Georgia, United States

Site Status

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

Pearlman Comprehensive Cancer Center at South Georgia Medical Center

Valdosta, Georgia, United States

Site Status

Saint Anthony's Hospital at Saint Anthony's Health Center

Alton, Illinois, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

St. Joseph Medical Center

Bloomington, Illinois, United States

Site Status

Graham Hospital

Canton, Illinois, United States

Site Status

Memorial Hospital

Carthage, Illinois, United States

Site Status

Eureka Community Hospital

Eureka, Illinois, United States

Site Status

Galesburg Clinic

Galesburg, Illinois, United States

Site Status

Galesburg Cottage Hospital

Galesburg, Illinois, United States

Site Status

Mason District Hospital

Havana, Illinois, United States

Site Status

Hopedale Medical Complex

Hopedale, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

McDonough District Hospital

Macomb, Illinois, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

BroMenn Regional Medical Center

Normal, Illinois, United States

Site Status

Community Cancer Center

Normal, Illinois, United States

Site Status

Community Hospital of Ottawa

Ottawa, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

Site Status

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Site Status

Proctor Hospital

Peoria, Illinois, United States

Site Status

CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

Site Status

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF St. Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois Valley Community Hospital

Peru, Illinois, United States

Site Status

Perry Memorial Hospital

Princeton, Illinois, United States

Site Status

St. Margaret's Hospital

Spring Valley, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Cedar Rapids Oncology Associates

Cedar Rapids, Iowa, United States

Site Status