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Phase II/III Randomized Study of Paclitaxel and Carboplatin With or Without Bevacizumab in Patients With Advanced, Metastatic, or Recurrent Non-Squamous Cell Non-Small Cell Lung Cancer
Alternate Title Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer
Special Category: CTSU trial Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Patient Characteristics: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment A total of 842 patients will be accrued for this study. Outline This is a randomized study. Patients are stratified according to measurable disease (yes vs no), prior radiotherapy (yes vs no), weight loss (less than 5% vs 5% or more), and disease stage (IIIB vs IV vs recurrent). Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients in arm II with stable or responding disease continue to receive bevacizumab only. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. Published ResultsDowlati A, Gray R, Sandler AB, et al.: Cell adhesion molecules, vascular endothelial growth factor, and basic fibroblast growth factor in patients with non-small cell lung cancer treated with chemotherapy with or without bevacizumab--an Eastern Cooperative Oncology Group Study. Clin Cancer Res 14 (5): 1407-12, 2008.[PUBMED Abstract] Ramalingam SS, Dahlberg SE, Langer CJ, et al.: Outcomes for elderly, advanced-stage non small-cell lung cancer patients treated with bevacizumab in combination with carboplatin and paclitaxel: analysis of Eastern Cooperative Oncology Group Trial 4599. J Clin Oncol 26 (1): 60-5, 2008.[PUBMED Abstract] Somer RA, Sherman E, Langer CJ: Restrictive eligibility limits access to newer therapies in non-small-cell lung cancer: the implications of Eastern Cooperative Oncology Group 4599. Clin Lung Cancer 9 (2): 102-5, 2008.[PUBMED Abstract] Cohen MH, Gootenberg J, Keegan P, et al.: FDA drug approval summary: bevacizumab (Avastin) plus Carboplatin and Paclitaxel as first-line treatment of advanced/metastatic recurrent nonsquamous non-small cell lung cancer. Oncologist 12 (6): 713-8, 2007.[PUBMED Abstract] Ramalingam SS, Dahlberg SE, Langer CJ, et al.: Outcomes for elderly advanced stage non-small cell lung cancer (NSCLC) patients (pts) treated with bevacizumab (B) in combination with carboplatin (C) and paclitaxel (P): analysis of Eastern Cooperative Oncology Group (ECOG) 4599 study. [Abstract] J Clin Oncol 25 (Suppl 18): A-7535, 393s, 2007. Brahmer JR, Gray R, Schiller JH, et al.: ECOG 4599 phase III trial of carboplatin and paclitaxel ±bevacizumab: subset analysis of survival by gender. [Abstract] J Clin Oncol 24 (Suppl 18): A-7036, 373s, 2006. Dowlati A, Gray R, Johnson DH, et al.: Prospective correlative assessment of biomarkers in E4599 randomized phase II/III trial of carboplatin and paclitaxel ± bevacizumab in advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 24 (Suppl 18): A-7027, 370s, 2006. Sandler AB, Johnson DH, Brahmer J, et al.: Retrospective study of clinical and radiographic risk factors associated with early onset, severe pulmonary hemorrhage in bevacizumab-treated patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 24 (Suppl 18): A-7068, 381s, 2006. Sandler A, Gray R, Perry MC, et al.: Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355 (24): 2542-50, 2006.[PUBMED Abstract] Sandler AB, Gray R, Brahmer J, et al.: Randomized phase II/III trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): an Eastern Cooperative Oncology Group (ECOG) Trial - E4599. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA4, 2s, 2005. Tyagi P: Bevacizumab, when added to paclitaxel/carboplatin, prolongs survival in previously untreated patients with advanced non-small-cell lung cancer: preliminary results from the ECOG 4599 trial. Clin Lung Cancer 6 (5): 276-8, 2005.[PUBMED Abstract] Related PublicationsSandler A: Bevacizumab in non small cell lung cancer. Clin Cancer Res 13 (15): 4613s-6s, 2007. Dornbusch D, Allegra C, Willey J, et al.: How do U.S. medical oncologists learn and apply new clinical trials information from press releases in nonmedical media? A case study based on ECOG 4599. Oncologist 11 (1): 31-8, 2006.[PUBMED Abstract] Gray R, Giantonio BJ, O'Dwyer PJ, et al.: The safety of adding angiogenesis inhibition into treatment for colorectal, breast, and lung cancer: the Eastern Cooperative Oncology Group's (ECOG) experience with bevacizumab (anti-VEGF). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-825, 2003. Trial Lead Organizations Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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