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Therapeutic Areas: Oncology
Disease Category: Non-Small Cell Lung Cancer

Trial Information

A Multicenter, Open-Label, Randomized, Phase II Trial of Docetaxel, Carboplatin and Bevacizumab as First-Line Treatment, Followed by Bevacizumab plus Pemetrexed versus Pemetrexed Alone as Second-Line Treatment of Stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC)

Primary Objective

• Progression-free survival (PFS) of bevacizumab and pemetrexed compared to pemetrexed monotherapy during second-line treatment of Stage IIIB or IV NSCLC.

Secondary Objectives

• Overall Survival (OS)
• Objective tumor response (objective response rate [ORR]) in second-line treatment
• Progression-free survival (PFS) in first-line and maintenance treatment
• Objective tumor response (objective response rate [ORR]) in first-line and maintenance treatment
• Treatment safety in first-line, maintenance and second-line treatment

Patient Exclusion Criteria:

• Age = 18 years
• Histologically or cytologically confirmed stage IIIB with malignant pleural effusion or stage IV NSCLC except squamous-cell carcinoma.
• Measurable disease defined by RECIST.
• Adequate organ function
• ECOG Performance Status 0-1
• Estimated survival of = 12 weeks
• Provide written informed consent

Patient Exclusion Criteria:

• Prior chemotherapy for advanced NSCLC
• Neoadjuvant or adjuvant treatment within 6 months of registration
• Prior radiation therapy within 3 weeks of registration. All side effects must have resolved by registration
• Prior treatment with an investigational or marketed agent that acts by antiangiogenesis mechanisms
• Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels unless treated with palliative radiation
• Brain metastases or leptomeningeal disease, except for patients who have had a resection and/or completed a course of cranial irradiation, have no worsening CNS symptoms, and have discontinued all corticosteroids for that indication for at least 1 month prior to registration
• History of gross hemoptysis (defined as bright red blood of at least ½ teaspoon or 2.5 mL per episode) within 3 months of registration unless definitively treated with surgery, radiation, arteriographic embolization, or endobronchial interventions at least 4 weeks prior to registration
• Presence of cavitory lesion
• Presence of squamous histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable)
• Peripheral neuropathy > grade 1
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of registration or anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures, fine needle aspirations or core biopsies within 1 week prior to registration
• Current, ongoing therapeutic anticoagulation with full-dose warfarin or its equivalent
• Current or recent (within 10 days of the first dose of study treatment) use of aspirin (at least 325 mg/day) or other NSAIDs with antiplatelet activity or treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), or cilostazol (Pletal)
• History of prior malignancy within the past 3 years except for curatively treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or treated localized prostate cancer with a current PSA of < 1.0 mg/dL on two successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to registration
• History of serious systemic disease
• Pregnancy or women who are breast-feeding. Women of childbearing potential and non-vasectomized men must agree to use effective methods of birth control during and 3 months following treatment period. Women of child-bearing potential must have a negative pregnancy test.
• History of severe hypersensitivity reaction to docetaxel or any other drugs formulated with polysorbate 80
• Any other medical condition, including mental illness or substance abuse, which in the judgment of the investigator, is likely to interfere with a patient’s ability to provide informed consent, cooperate, and participate in the study, or to interfere with the interpretation of the results
• Anticipation of concurrent therapy to treat NSCLC during the study treatment period
• Use of any investigational agent within 4 weeks prior to registration

Cathy Spears, RN, Manager
St. Francis Hospital and Health Centers
1500 Albany Street, Ste. 1001
Beech Grove, IN 46107
Phone: 317-782-7820
Fax: 317-782-7828
EMail: Cathy.Spears@ssfhs.org

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Research Center Information: St. Francis Hospital and Health Centers

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