A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer
NCT ID: NCT00762034
Last Updated: 2015-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
939 participants
INTERVENTIONAL
2008-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pem/Carbo/Bev
Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab
Pemetrexed
Induction therapy 500 milligram per meter squared (mg/m\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed
Maintenance therapy 500 mg/m\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Carboplatin
Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days
Bevacizumab
Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days
Bevacizumab
Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Pac/Carbo/Bev
Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab
Paclitaxel
Induction therapy 200 mg/m\^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Carboplatin
Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days
Bevacizumab
Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days
Bevacizumab
Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Interventions
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Pemetrexed
Induction therapy 500 milligram per meter squared (mg/m\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Pemetrexed
Maintenance therapy 500 mg/m\^2 IV every 21 days (with bevacizumab) until progressive disease or treatment discontinuation
Paclitaxel
Induction therapy 200 mg/m\^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days
Carboplatin
Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days
Bevacizumab
Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days
Bevacizumab
Maintenance therapy 15 mg/kg IV every 21 days until progressive disease or treatment discontinuation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Fayetteville, Arkansas, United States
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Jonesboro, Arkansas, United States
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Alhambra, California, United States
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Bakersfield, California, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Fullerton, California, United States
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La Verne, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Rancho Mirage, California, United States
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Redondo Beach, California, United States
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Santa Barbara, California, United States
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Santa Maria, California, United States
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Santa Rosa, California, United States
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Grand Junction, Colorado, United States
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Boca Raton, Florida, United States
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Coral Springs, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Melbourne, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Port Saint Lucie, Florida, United States
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Stuart, Florida, United States
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Athens, Georgia, United States
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Augusta, Georgia, United States
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Fort Gordon, Georgia, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Skokie, Illinois, United States
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New Albany, Indiana, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Chevy Chase, Maryland, United States
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Frederick, Maryland, United States
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Rockville, Maryland, United States
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Boston, Massachusetts, United States
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Framingham, Massachusetts, United States
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Lambertville, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Stony Brook, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Kittanning, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Columbia, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Abingdon, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
Countries
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References
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Spigel DR, Patel JD, Reynolds CH, Garon EB, Hermann RC, Govindan R, Olsen MR, Winfree KB, Chen J, Liu J, Guba SC, Socinski MA, Bonomi P. Quality of life analyses from the randomized, open-label, phase III PointBreak study of pemetrexed-carboplatin-bevacizumab followed by maintenance pemetrexed-bevacizumab versus paclitaxel-carboplatin-bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):353-9. doi: 10.1097/JTO.0000000000000277.
Reynolds CH, Patel JD, Garon EB, Olsen MR, Bonomi P, Govindan R, Pennella EJ, Liu J, Guba SC, Li S, Spigel DR, Hermann RC, Socinski MA, Obasaju CK. Exploratory Subset Analysis of African Americans From the PointBreak Study: Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 May;16(3):200-8. doi: 10.1016/j.cllc.2014.11.004. Epub 2014 Nov 18.
Patel JD, Socinski MA, Garon EB, Reynolds CH, Spigel DR, Olsen MR, Hermann RC, Jotte RM, Beck T, Richards DA, Guba SC, Liu J, Frimodt-Moller B, John WJ, Obasaju CK, Pennella EJ, Bonomi P, Govindan R. PointBreak: a randomized phase III 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. J Clin Oncol. 2013 Dec 1;31(34):4349-57. doi: 10.1200/JCO.2012.47.9626. Epub 2013 Oct 21.
Patel JD, Bonomi P, Socinski MA, Govindan R, Hong S, Obasaju C, Pennella EJ, Girvan AC, Guba SC. Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2009 Jul;10(4):252-6. doi: 10.3816/CLC.2009.n.035.
Other Identifiers
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H3E-MC-JMHD
Identifier Type: OTHER
Identifier Source: secondary_id
9707
Identifier Type: -
Identifier Source: org_study_id