Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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


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 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
(e.g. 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 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

Baseline to date of death from any cause

Safety Issue:

Yes

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMC - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

9707

NCT ID:

NCT00762034

Start Date:

December 2008

Completion Date:

April 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

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.Denver, Colorado  
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.Manhassaet, New York  
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.Durham, North Carolina  
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.Greenbrae, California  94904
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.Jacksonville, Florida  32256
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.Athens, Georgia  30607
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.Chicago, Illinois  60674
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.Indianapolis, Indiana  46227
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.Overland Park, Kansas  66210
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.Metairie, Louisiana  70006
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.Bethesda, Maryland  20817
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.Kalamazoo, Michigan  49048
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.Minneapolis, Minnesota  55404
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.St Joseph, Missouri  64507
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.Las Vegas, Nevada  89169
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.Cincinnati, Ohio  45267
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.Tulsa, Oklahoma  74136
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.Dunmore, Pennsylvania  18512
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.Greenville, South Carolina  29605
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Norfolk, Virginia  23502
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.Seattle, Washington  98133
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.Marshfield, Wisconsin  54449
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.Little Rock, Arkansas  72205
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.Springfield, Massachusetts  
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.Lexington, Kentucky  40536