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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079040 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. 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 deliver tumor-killing substances to them. Giving chemotherapy with a monoclonal antibody may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with bevacizumab works in treating patients with previously untreated extensive-stage small cell lung cancer.
| Condition | Intervention | Phase |
|
Lung Cancer |
Drug: bevacizumab Drug: cisplatin Drug: etoposide |
Phase II |
| MedlinePlus related topics: | Cancer Lung Cancer |
| Drug Information available for: | Etoposide Cisplatin Bevacizumab Etoposide phosphate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study of Cisplatin Plus Etoposide (PE) Plus Bevacizumab (NSC #704865) for Previously Untreated Extensive Stage Small Cell Lung Cancer |
| Estimated Enrollment: | 66 |
| Study Start Date: | June 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are followed every 2 months for up to 3 years from study entry.
PROJECTED ACCRUAL: A total of 27-66 patients will be accrued for this study within 3-8 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Proteinuria < 1+
Cardiovascular
No arterial thromboembolic event within the past 6 months, including any of the following:
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
No concurrent treatment with any of the following:
Contacts and Locations![]() |
Show 60 Study Locations |
| Eastern Cooperative Oncology Group |
| National Cancer Institute (NCI) |
| Study Chair: | Alan B. Sandler, MD | Vanderbilt-Ingram Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Sandler A, Szwaric S, Dowlati A, et al.: A phase II study of cisplatin (P) plus etoposide (E) plus bevacizumab (B) for previously untreated extensive stage small cell lung cancer (SCLC) (E3501): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-7564, 400s, 2007.
  |
| Study ID Numbers: | CDR0000353484, ECOG-E3501 |
| First Received: | March 8, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00079040 |
| Health Authority: | United States: Food and Drug Administration |
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