Status:
COMPLETED
A Study of Pemetrexed, Carboplatin and Bevacizumab in Participants With Nonsquamous Non-Small Cell Lung Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
939 Patients enrolled
Trial Details
Trial ID
NCT00762034
Start Date
December 1 2008
End Date
December 1 2014
Last Update
December 21 2015
Active Locations (67)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fayetteville, Arkansas, United States, 72703
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jonesboro, Arkansas, United States, 72401
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Alhambra, California, United States, 91801
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bakersfield, California, United States, 93309