A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2008
End Date:December 2014

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Randomized, Open-Label, Phase 3 Study of Pemetrexed Plus Carboplatin and Bevacizumab Followed by Maintenance Pemetrexed and Bevacizumab Versus Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB or IV Nonsquamous Non-Small Cell Lung Cancer

This study will compare overall survival in participants with Stage IIIB or IV nonsquamous
non-small cell lung cancer.


Inclusion Criteria:

- You must sign an informed consent document for clinical research.

- You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.

- You must not have received any prior treatment for your disease.

- Prior radiation therapy is allowed to < 25% of the bone marrow; however, prior
radiation to the whole pelvis is not allowed. If you have had radiation therapy to
the chest, you are not eligible to participate.

- You must be at least 18 years of age or older.

- You must have measureable tumor lesions according to the Response Evaluation Criteria
in Solid Tumors (RECIST) or disease can be evaluated on computed tomography (CT)
scan.

- Your test results assessing the function of blood forming tissue, kidneys and liver
must be satisfactory.

- Women must be sterile, postmenopausal or on contraception and men must be sterile
(for example post-vasectomy) or on contraception.

Exclusion Criteria:

- You cannot have clinically significant third-space fluid collections (e.g. ascites or
pleural effusions that cannot be controlled by drainage or other procedures).

- You cannot have Non-small Cell Lung Carcinoma (NSCLC) of predominantly squamous cell
histology.

- You cannot have known central nervous system (CNS) disease, other than stable,
treated brain metastasis.

- You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or
significant traumatic injury within 28 days of starting the study treatment, or have
an anticipated need for major surgery during the study.

- You cannot have a history of gastrointestinal fistula, perforation, or abscess,
inflammatory bowel disease, or diverticulitis.

- You are currently receiving ongoing treatment with full-dose warfarin or equivalent.

- You cannot have significant vascular disease, serious cardiac conditions (such as
heart attack), stroke or transient ischemic attack within 6 months of the trial.

- You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of
therapeutic anticoagulation).

- You cannot have inadequately controlled hypertension, or a history of hypertensive
crisis or hypertensive encephalopathy.

- You cannot have a serious, nonhealing wound, active ulcer, or untreated bone
fracture.

- You cannot have another form of cancer, other than superficial basal cell and
superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last
5 years.

- You cannot have received an investigational treatment within 30 days prior to the
trial.

- You cannot have previously received treatment with paclitaxel, carboplatin,
pemetrexed, or bevacizumab.

- You cannot be pregnant or breast-feeding.

- You cannot have a known sensitivity to any component of paclitaxel, carboplatin,
pemetrexed, or bevacizumab.

- You cannot have a history of hemoptysis (coughing blood) within 3 months prior to the
trial.

- You are unable to stop taking aspirin more than 1.3 grams per day or other
nonsteroidal anti-inflammatory drugs (NSAIDs).

- You are unable or unwilling to take folic acid or vitamin B12 supplementation.

- You are unable to take corticosteroids.

- You have any other on-going illnesses including active infections that may not allow
you to adhere to the requirements of the trial.
We found this trial at
67
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Orlando, FL
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Abingdon, VA
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Alhambra, CA
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411
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Athens, GA
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457
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Augusta, GA
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1980
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Bakersfield, CA
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344
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Baltimore, MD
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801
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Baton Rouge, LA
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323
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Bethesda, MD
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955
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Boca Raton, FL
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643
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Boston, MA
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Bronx, NY
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353
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Chapel Hill, NC
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323
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Chevy Chase, MD
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274
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Chicago, IL
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98
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Cincinnati, OH
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426
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Columbia, SC
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Columbus, OH
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Coral Springs, FL
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Duarte, CA
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Duluth, MN
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659
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Fayetteville, AR
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454
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Fort Gordon, GA
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922
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Fort Myers, FL
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Fountain Valley, California 92708
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Fountain Valley, CA
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Framingham, Massachusetts 01702
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Framingham, MA
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Frederick, MD
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1958
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Fullerton, CA
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Grand Junction, CO
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303
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Gurnee, IL
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Jacksonville, FL
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Jonesboro, AR
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Kittanning, PA
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283
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Knoxville, TN
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La Verne, CA
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Lake Worth, FL
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128
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Lambertville, MI
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Long Beach, CA
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Los Angeles, CA
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Louisville, KY
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Melbourne, FL
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Memphis, TN
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335
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Milwaukee, WI
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624
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Minneapolis, MN
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189
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New Albany, IN
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1982
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Northridge, CA
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849
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Oklahoma City, OK
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Pembroke Pines, FL
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Port St Lucie, FL
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Rancho Mirage, California 90070
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Rancho Mirage, CA
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Redondo Beach, California 90277
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Redondo Beach, CA
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Reno, NV
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Richmond, VA
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Rockville, MD
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San Antonio, TX
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Santa Barbara, California 93105
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Santa Barbara, CA
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Santa Maria, CA
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Santa Rosa, CA
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Skokie, IL
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St Louis, MO
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Stony Brook, NY
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Stuart, FL
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2012
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Tacoma, WA
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The Woodlands, TX
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Tulsa, OK
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Wichita, KS
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Willow Grove, Pennsylvania 19090
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Willow Grove, PA
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