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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Bevacizumab; Carboplatin; Paclitaxel; Pemetrexed

Criteria

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.