Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00268489
First received: December 20, 2005
Last updated: June 17, 2012
Last verified: January 2007

December 20, 2005
June 17, 2012
May 2006
May 2007   (final data collection date for primary outcome measure)
Proportion of progression-free patients at 3 months [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00268489 on ClinicalTrials.gov Archive Site
  • Response (complete and partial) as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
Not Provided
Not Provided
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Pemetrexed Disodium and Bevacizumab in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase II Study of Pemetrexed Disodium (ALIMTA®) Plus Bevacizumab in Patients With Stage IIIB Pleural Effusion or Stage IV Non-Small Cell Lung Cancer (Second-Line Treatment)

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, 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 tumor cells by blocking blood flow to the tumor. Giving pemetrexed disodium together with bevacizumab may be an effective treatment for non-small cell lung cancer.

PURPOSE: This phase II trial is studying how well giving pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

  • Assess the 3 month progression-free survival rate of the combination of pemetrexed disodium with bevacizumab in a patient population with stage IIIB (due to pleural effusion) or IV non-small cell lung cancer.

Secondary

  • Determine the tumor response rate in these patients.
  • Determine the effect of pemetrexed disodium in combination with bevacizumab on overall survival and duration of response in these patients.
  • Determine the toxicity profile of this drug regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Biological: bevacizumab
  • Drug: pemetrexed disodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
Not Provided
May 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically diagnosed stage IIIB or IV non-small cell lung cancer

    • Stage IIIB patients must have pleural effusion

      • No symptomatic serosal effusion (grade 2 dyspnea) that is not amenable to drainage
    • Mixed histology allowed if all components consistent with non-small cell lung cancer
    • Tumors with squamous cell histology feature are allowed
  • Must have measurable disease with at least one lesion with a longest diameter accurately measured as ≥ 2.0 cm with conventional techniques or as ≥ 1.0 cm with spiral CT

    • Large ( > 4 cm) centrally located lesions or large lesions in close proximity to major blood vessels should receive palliative radiation

      • The irradiated lesion should not be a target lesion
  • Previously treated with one chemotherapy regimen in the neoadjuvant, adjuvant, or advanced disease setting
  • No symptomatic, untreated, or uncontrolled CNS metastases

    • CNS metastases treated with prior whole brain radiotherapy allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/ mm^3
  • Hemoglobin ≥ 9 g/dL
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin normal
  • AST and ALT ≤ 3 times ULN (5 times ULN if liver has tumor involvement)
  • Creatinine clearance ≥ 45 mL/min
  • Urine protein:creatinine ratio < 1.0
  • Pregnant or nursing women are ineligible
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No seizure disorder
  • No clinically significant infection
  • No other second primary malignancy within the past 5 years except carcinoma in situ of the cervix, non-melanomatous skin cancer, or low-grade (Gleason score ≤ 6) localized prostate cancer
  • No hypertension or labile hypertension
  • No history of poor compliance with antihypertensive medications
  • No angina pectoris
  • No congestive heart failure within the past 3 months unless ejection fraction > 40%
  • No myocardial infarction within the past 6 months
  • No cardiac arrhythmia
  • No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
  • No active or recent history of hemoptysis

    • Hemoptysis resolved > 2 weeks ago with measures such as palliative radiation therapy (i.e., 3,000 cGy over 10 fractions), arteriographic embolization, or endobronchial interventions (e.g., photodynamic therapy or brachytherapy) is acceptable
  • No diabetes
  • No prior serious, non-healing wounds, ulcers, or bone fractures
  • No history of stroke within the past 6 months
  • No history of abdominal fistula or gastrointestinal perforation
  • No intra-abdominal abscess within the past 6 months
  • Not at greater than average risk of bleeding
  • No significant traumatic injury within the past 4 weeks

PRIOR CONCURRENT THERAPY:

  • No aspirin at doses ≥ 1.3 grams per day within 10 days prior to or 10 days after pemetrexed disodium treatment
  • No chemotherapy within the past 3 weeks (6 weeks for mitomycin C or nitrosoureas)
  • No immunotherapy or biologic therapy within the past 2 weeks
  • No full field radiation therapy within the past 4 weeks or limited field radiation therapy within the past 2 weeks

    • The site of previous radiotherapy should have evidence of progressive disease if it is the only site of disease
  • No prior post pelvic radiation
  • No prior use of pemetrexed disodium
  • No prior radiation to > 25% of the marrow cavity
  • No major surgery (i.e., laparotomy) or open biopsy within the past 4 weeks
  • No minor surgery within the past 2 weeks except insertion of a vascular access device
  • No concurrent major surgery
  • No other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or any ancillary therapy considered investigational within the past 4 weeks
  • No concurrent use of Hypericum perforatum (St. John's wort)
  • No concurrent anticoagulant use

    • Low-dose warfarin or heparin for deep venous thrombosis prophylaxis allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00268489
CDR0000456427, NCCTG-N0426, SWOG-N0426
Not Provided
Not Provided
North Central Cancer Treatment Group
  • National Cancer Institute (NCI)
  • Southwest Oncology Group
Study Chair: Alex A. Adjei, MD, PhD Roswell Park Cancer Institute
Investigator: Donald B. Wender, MD, PhD St. Luke's Regional Medical Center
Study Chair: Ralph G. Zinner, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP