Bevacizumab or Pemetrexed Disodium Alone or In Combination After Induction Therapy in Treating Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT01107626 |
Recruitment Status
:
Active, not recruiting
First Posted
: April 21, 2010
Last Update Posted
: February 8, 2017
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer | Biological: bevacizumab Drug: pemetrexed disodium | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1282 participants |
Allocation: | Randomized |
Masking: | None (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 |
Study Start Date : | August 2010 |
Estimated Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | April 1, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1
|
Biological: bevacizumab
Given IV
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Experimental: Arm II
Patients receive pemetrexed IV over 10 minutes on days 1.
|
Drug: pemetrexed disodium
Given IV
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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
|
- Overall survival
- Progression-free survival
- Objective response as measured by RECIST
- Toxicity
- Association between bevacizumab and pemetrexed disodium population pharmacokinetics
- Association between proteomic profiles and ICAM, VEGF, and FGF-beta with the clinical outcomes (Closed as of 04/01/2010)

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Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Cytologically or histologically confirmed non-small cell lung cancer (NSCLC)
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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
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107626

Principal Investigator: | Suresh Ramalingam, MD | Emory University |
Responsible Party: | Eastern Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT01107626 History of Changes |
Other Study ID Numbers: |
CDR0000666482 ECOG-E5508 |
First Posted: | April 21, 2010 Key Record Dates |
Last Update Posted: | February 8, 2017 |
Last Verified: | February 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Eastern Cooperative Oncology Group:
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:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Bevacizumab |
Pemetrexed Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |