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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborator: |
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 |
Biological: bevacizumab Drug: cisplatin Drug: etoposide |
Phase II |
| 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 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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| Study Chair: | Alan B. Sandler, MD | Vanderbilt-Ingram Cancer Center |
More Information
| Study ID Numbers: | CDR0000353484, ECOG-E3501 |
| Study First Received: | March 8, 2004 |
| Last Updated: | May 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00079040 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
extensive stage small cell lung cancer |
|
Thoracic Neoplasms Carcinoma, Neuroendocrine Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Bevacizumab Etoposide phosphate Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |
Etoposide Respiratory Tract Neoplasms Neoplasms by Histologic Type Growth Substances Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Lung Diseases Adenocarcinoma Antineoplastic Agents, Phytogenic |