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Clinical Trial ECOGTHNE5508

Title

Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Premetrexed, or Combination of Bevacizumab and Premtrexed following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC

Principal Investigator(s)

Leora Horn

Details

  • Protocol No. ECOGTHNE5508
  • Open Date: 06/29/2011
  • Staging: Phase III
  • Age Group: Adults
  • Scope: National
  • Objective: To compare the overall survival associated with maintenance therapy with bevacizumab, pemetrexed or the combination in patients with advanced stage NSCLC
  • Disease Sites: Lung; Non Small Cell
  • Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: Alimta; Avastin; Bevacizumab; Carboplatin; Paclitaxel; Pemetrexed
  • Participating Institutions: Jackson-Madison County HospitalVanderbilt University
  • National Clinical Trial ID: NCT01107626
  • Secondary Protocol No: E5508

Description

The purpose of this study is to find out the best maintenance therapy for patients with advanced stage non-small cell lung cancer. Maintenance therapy is usually given after 4 cycles of standard chemotherapy (1 cycle = 21 days) to keep the disease under control for a longer duration. This study will compare the effects, good and/or bad, of bevacizumab, pemetrexed or the combination of the two agents when given as maintenance therapy.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

DISEASE CHARACTERISTICS:
• Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)
• Predominant non-squamous histology
• NSCLC not otherwise specified allowed
• Mixed tumors are categorized by the predominant cell type
• Must meet 1 of the following criteria:
• Stage IV disease including M1a or M1b stages or recurrent disease
• Stage IIIB (T4NX) disease with ipsilateral lung lobe allowed provided patients are not candidates for combined chemotherapy or radiotherapy
• Measurable or non-measurable disease as defined by RECIST criteria
• Patient must have an overall stable or better response after 4 courses of induction therapy
• No cavitary lesions in the lungs
• Patients with brain metastasis must have received local therapy to the brain and have no evidence of progression in the brain for at least 2 weeks from the time of completion of local therapy, prior to registration
PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• Leukocytes ≥ 3,000/mm^3
• ANC ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Total bilirubin ≤ institutional upper limit of normal (ULN)
• AST and ALT ≤ 3 times ULN
• Creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min
• Urine protein:urine dipstick ≤ 0-1+ (if > 1+, urine protein creatinine ratio must be < 1)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must agree to abstain from sexual intercourse or to use adequate contraceptive methods during and for at least 6 months after completion of study therapy
• No prior malignancy within the past 3 years except superficial melanoma, basal cell carcinoma, or carcinoma in situ
• No major hemoptysis within the past 4 weeks
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Serious cardiac arrhythmia
• Psychiatric illness and/or social situations that would limit compliance with study requirements
• Patients with hypertension must be adequately controlled (BP < 150/100 mm Hg) with appropriate anti-hypertensive therapy or diet
• No history of arterial thrombotic events or major bleeding within the past 12 months
• No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within the past 6 months
• No significant traumatic injury in the past 3 months
• No clinically significant cardiovascular disease
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No history of serious non-healing wounds, ulcers, or bone fractures
PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• At least 12 months since prior adjuvant chemotherapy
• At least 2 weeks since prior radiotherapy
• Patients must not have had any major surgery such as thoracotomy, laparotomy, craniotomy, or significant traumatic injury within 6 weeks prior to registration
• Biopsy procedures and chest tube insertion are not considered major surgery for the purpose of this protocol
• More than 7 days since a core biopsy
• Concurrent therapeutic anti-coagulation allowed
• No prior systemic chemotherapy for advanced stage lung cancer
• No prior paclitaxel, pemetrexed disodium, or bevacizumab
• Prior carboplatin allowed provided it was given as part of adjuvant chemotherapy
• No concurrent anti-retroviral therapy in patients with HIV infection