Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01107626
First received: April 20, 2010
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Pemetrexed disodium may stop the growth of tumor cells by blocking some enzymes needed for cell growth. It is not yet known whether giving bevacizumab or pemetrexed disodium alone or in combination is more effective in treating non-squamous non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying bevacizumab and pemetrexed disodium alone or in combination after induction therapy to see how well they work in treating patients with advanced non-squamous non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: bevacizumab
Drug: pemetrexed disodium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Study of Maintenance Therapy With Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Objective response as measured by RECIST [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Association between bevacizumab and pemetrexed disodium population pharmacokinetics [ Designated as safety issue: No ]
  • Association between proteomic profiles and ICAM, VEGF, and FGF-beta with the clinical outcomes (Closed as of 04/01/2010) [ Designated as safety issue: No ]

Estimated Enrollment: 1282
Study Start Date: August 2010
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1
Biological: bevacizumab
Given IV
Experimental: Arm II
Patients receive pemetrexed IV over 10 minutes on days 1.
Drug: pemetrexed disodium
Given IV
Experimental: Arm III
Patients receive bevacizumab as in arm I and pemetrexed as in arm II.
Biological: bevacizumab
Given IV
Drug: pemetrexed disodium
Given IV

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  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107626

  Show 434 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Suresh Ramalingam, MD Winship Cancer Institute of Emory University
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01107626     History of Changes
Other Study ID Numbers: CDR0000666482, ECOG-E5508
Study First Received: April 20, 2010
Last Updated: December 5, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
bronchoalveolar cell lung cancer
large cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014